Total 28 affairs manager job vacancies in Quality Assurance / Control category in d18 tampines pasir ris

DESCRIPTION

The Regulatory Compliance Manager reports to the Project Director and shall be responsible for the effective design effort and coordination of the Sub-Contractor's discipline engineering professionals. The Regulatory Compliance Manager shall ensure that all de-signs comply with the requirements of the Work; that all Work is efficiently and effectively executed in accordance with the criteria, specifications and standards listed in the CONTRACT; and that the designs comply with safe and reasonable standards as accepted within the offshore oil and gas industry. The Regulatory Compliance Manager shall be responsible for his/her scope of work as given below:

DUTIES & RESPONSIBILITIES

• Develop Regulatory Permits & Consents Compliance Plan for the project including all active and passive statutory and Classification compliance requirements.
• Review Compliance Plan with Client and Class Authority, and report as necessary.
• Monitor changes in regulations to ensure the project is designed and installed to satisfy the correct edition of statutory and Classification requirements.
• Inform all disciplines of Regulatory and Classification requirements.
• Monitor the submission of Regulatory Compliance documentation and maintain master file of all Regulatory Permits & Consents.
• Monitor the issue of acceptance or permits by the Regulatory bodies and Classification society.
• Handover Regulatory Permits & Consents Compliance Plan to CLIENT/Operator indicating dates when permits and consents are required to be renewed.
• As necessary, participate with Project Management in negotiation and establishment of contracts for Class review and Regulatory Compliance at bid, FEED, or sanction stages of project.
• Provide Regulatory audit functions for accuracy of PO certification and inspection requirements within Regulatory Compliance scope (Vendor Compliance).
• Collect and promulgate Regulatory lesson learned during project.
• Support project team with respect to availability of appropriate / applicable codes and standards from Company reference library resource.

Comply with HSE requirements:

• Environmental Aspects & Impacts Assessment.
• OHS Hazardous & Risk Assessment.
• Follow HSE Regulations.

REQUIREMENTS

• Minimum educational requirements of a Bachelors’ and/or Masters’ degree in Mechanical / Chemical / petroleum Engineering or equivalent.
• Direct experience working on FPSO projects.
• Experience working with regulatory bodies in West Africa, China, and Europe.
• Minimum 15-18 years’ experience, with Oil & Gas projects (fixed installations and FPSOs), with significant experience working as a Project Manager or Lead Engineer.
• Must have prior work experience with medium/ large sized brownfield and/or greenfield projects in the upstream Oil and Gas sector, in a similar role and possess a good understanding of project phases, milestones, deliverables, internal and external interfaces.
• Good leadership skills to manage and develop a team.

Job Description & Responsibilities:

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
• Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
• Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
• Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
• Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
• Ensure that regulatory records are controlled and maintained.
• Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.

Job Requirements:

• Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
• Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge of Health Sciences Authority requirement for IVD product submission.
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Experience with product registration submission and evaluation.
• Experience with maintaining internal regulatory database.
• Experience with Dossier Creation.
• Ability to develop and implement plans for regulatory submission.
• Awareness of applicable workplace environment, health and safety regulations.
• Ability to network and build strategic partnership with good problem solving skills and communication skills.
• Possess leadership and agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

COMPANY DESCRIPTION

About BW Group

BW Group is a leading global maritime company involved in shipping, floating infrastructure, deepwater oil & gas production, and new sustainable technologies. Founded in 1955 by Sir YK Pao, BW controls a fleet of over 450 vessels transporting oil, gas and dry commodities, with its 200 LNG and LPG ships constituting the largest gas fleet in the world. In the renewables space, the group has investments in solar, wind, batteries, biofuels and water treatment. BW is proud to be listed as one of Forbes World's Best Employers 2023.

Are you ready to make an impact?

What drives us is our mission to deliver energy for the world today, and to find solutions for tomorrow. If you want to make lives better around the world by providing access to energy, while working on sustainability and decarbonisation, we'd like to hear from you. Working at BW you will feel the pulse of the world each day. If something happens in the world, we feel it, and you can play your part by anticipating and responding to it. Our high-performing teams are drawn to BW by the global nature of our work and the satisfaction of working with collaborative people who inspire each other to deliver exceptional results.

RESPONSIBILITIES

We are seeking a highly skilled and experienced IT Compliance and Cyber Risk Manager to join our dynamic IT team. This role is crucial in ensuring our IT operations comply with IT general controls, SOX controls, and other regulatory requirements. Additionally, the manager will lead our Cyber Risk Quantification Program, identifying and mitigating cyber risks to protect our company's assets and reputation.

Responsibilities:

• Compliance Management:
• Ensure all IT operations comply with IT general controls, SOX controls, and other relevant framworks the company chose to company chose to complay with (e.g. NIST CSF, CERT RMM) regulatory requirements.
• Develop, implement, and maintain IT compliance methodology, policies and procedures.
• Work with your IT colleguaes to ensure compliance with internal and external standards. Lead regular assessment with the IT organisation.
• Collaborate with internal and external auditors to facilitate compliance audits and address findings.

• IT-Risk Management:
• Manage the internal Cyber Risk Quantification Program with the company tools to identify, assess, and quantify cyber risks.
• Monitor and report on the effectiveness of IT risk management initiatives.
• Stay updated on the latest IT Risks, cyber threats and vulnerabilities.

• Policy and Procedure Development:
• Develop and maintain IT compliance and cyber risk management policies and procedures.
• Ensure policies and procedures are communicated effectively to all relevant stakeholders.
• Provide training and guidance to IT staff on compliance and risk management best practices.

• Collaboration and Communication:
• Work closely with other departments to ensure a cohesive approach to IT compliance and cyber risk management.
• Communicate effectively with senior management, providing regular updates on compliance status and IT-Risk management activities.
• Serve as the primary point of contact for IT compliance and risk management issues.

• Bachelor's degree in Information Technology, Computer Science, or a related field.
• Minimum of 5 years of experience in IT compliance, ITGC and/or SOX controls, and IT risk management.
• Strong knowledge of IT general controls, Framworks, and regulatory requirements.
• Experience with IT risk quantification and mitigation strategies.
• Excellent analytical, problem-solving, and communication skills.
• Relevant certifications such as CISA, CISSP, CRISC, or similar are highly desirable.
• Strong communication and interpersonal skills, with the ability to effectively engage with stakeholders at all levels.
• Ability to manage multiple tasks and deadlines in a fast-paced environment
• Eager Learner: Has a strong willingness to learn new things and continuously seeks to improve their skills and knowledge.
• Team Player: Works well in a team and contributes to a positive team environment.
• Problem Solver: Demonstrates strong problem-solving skills, with the ability to think critically and find creative solutions to challenges.
• Detail-Oriented: Pays close attention to detail and has a strong commitment to quality.
• Adaptable: Is flexible, can quickly adapt to new situations and changes in project scope or direction, understand the needs of his peers and contribute to a prefessional and enjoyable work environment.

At BW, we offer challenging work in an international environment with a team of dedicated and competent colleagues. We recognise that the success of BW rests with each employee's ability to provide the necessary skills and confidence within the team, and our training is tailored to suit individual needs and career aspirations.

Vision: Best on Water

Mission: We deliver energy for the world today, and find solutions for tomorrow

Values

• Collaborative
• Ambitious
• Reliable
• Enduring

If our values resonate with you and you think you can contribute, we would be delighted to hear from you!

Don't meet every single requirement? At BW, we value diversity and the unique experiences that people from different backgrounds bring to our business. We welcome you to apply for the role even if you don't fully meet all the listed requirements, especially if you are passionate about building an inclusive culture where we strive to be our best. You may be just the right candidate!

Information for Recruitment Agencies:

BW endeavours to recruit and fill vacancies directly. However, when we do need to engage with agencies, BW operates a preferred supplier list (PSL) and will not be accepting unsolicited applications from non-PSL agencies for this role.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Bachelor’s degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Master's degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Responsibilities:

• Manage daily QA duties and the QA/testing team.
• Develop and implement quality practices in methodologies and processes.
• Manage/support multiple QA projects.
• Develop QA plan and timeline.Recommend improvement to processes and practices to IT management and application team.

Note: Proceeding to apply on this job post means you have read, understand and agreed to WPH DATA PROTECTION NOTICE FOR JOB APPLICANTS in the link below.

https://www.wphdigital.com/notices

Job Description
• Manage a portfolio of clientele which include listed companies, SMEs and internationally active companies
• Manage a team of audit professionals and assist the Audit Partners and Directors in delivering assurance services to a portfolio of clients
• Perform review work of audit teams’ findings
• Develop and maintain long-term client relationships and identify business development opportunities
• Coach, mentor and build high performance teams

Job Requirement
• Degree or professional accounting qualifications recognised by ISCA
• Minimum 5 years’ relevant experience with large/mid-tier international accounting firms
• Strong technical (accounting/auditing standards) & interpersonal skills

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Send me your resume via WhatsApp ❤

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I regret to share that only shortlisted candidates will be notified. www.dadaconsultants.com

EA Registration Number: R22108564

Data provided is for recruitment purposes only

Business Registration Number: 201735941W.

Licence Number: 18S9037

Responsibilities:

• Lead and execute comprehensive audits for both listed companies and SMEs, locally and internationally, from planning through to completion, consistently meeting deadlines while demonstrating reliability and strong organizational skills as a key team member.
• Develop and apply effective problem-solving skills, providing actionable recommendations to management based on thorough industry research, insightful analysis, and investigative findings.
• Show initiative and uphold a strong work ethic, coaching junior staff, sharing knowledge, and understanding how individual contributions impact team performance and outcomes.
• Understand the role of the business unit within the broader firm context, actively building internal networks, and making meaningful contributions during client meetings alongside senior team members.

Requirements:

• Min Degree or professional accounting qualifications recognised by ISCA
• Minimum 2 years’ relevant experience with large/mid-tier international accounting firms
• Proactive, committed and able to work under pressure
• Possess initiative and the ability to work independently
• Team player

If you are interested, kindly apply through mycareersfuture.

I regret to share that only shortlisted candidates will be notified.

www.dadaconsultants.com

EA Registration Number: R21100604

Data provided is for recruitment purposes only

Business Registration Number: 201735941W.

Licence Number: 18S9037

Job description:

1. To plan, organize and monitor all activities relating to quality assurance to maintain quality standards and systems to meet customer requirements.

2. To define and control the characteristics of each part, affiliated with appropriate Inspection Plans; and make available the required facilities to verify these characteristics.

3. To oversee and approve First Article inspection procedures prior to sample submission to customers.

4. To issue material certificate to meet customer requirements.

5. To liaise with customers on matters related to quality.

6. To conduct/co-ordinate Material Review procedures to implement any Corrective/Preventive Action; and follow-up for a closure with result of satisfactory action taken.

7. To approve disposal of non-conforming items.

8. To ensure all inspections are conducted correctly.

9. To control and manage the Equipment Calibration System; setting the frequency of each calibration.

10. To report quality performance and critical discrepancy issues to General Manager.

11. To propose to General Manager an indicative rate of annual salary-increment and annual bonus of his subordinates reflected through the past year performance.

12. To approve the application of various type of Leave of his subordinates.

13. To approve petty-cash paid to his subordinates.

14. To recruit and upgrade his subordinates with relevant training programs and sue practical experiences.

15. To train subordinates in Sampling and Inspection techniques.

Experience Required:

At least 5 years experience in a Quality Control Management.

Skills required

1. Well-versed in ISO 9001:2000 requirement.

2. Quality Control System.

Qualification required

1. Mechanical/Manufacturing/Engineering Degree.

IT Exposure

1. Computer literate in MS Office.

2. Application knowledge in Autocad.

• Position : Quality Manager – Up to $8,000 – Changi South
• Location : Changi South
• Working hours : 5 Days Work Week – Monday to Friday: 7.30AM to 4.30PM
• Salary (commensurate with experience) : Up to $8,000 Basic + Transport Allowance + AWS + Performance Bonus + 12 Days Annual Leave + Medical & Dental Benefits
• Duration : Perm
• Industry : Industrial Gas

Responsibilities:

• Lead the Quality Department to implement effective quality assurance and control processes to ensure that the product delivered meet customers’ requirement and achieves company quality
• objectives.
• Ensure compliance to customers’ requirements throughout the organization.
• Collaborate with the Management Team and Stakeholders to define and implement the Company’s Quality Strategy.
• Manage and continuously improve company's Quality Systems in compliance with Company’s policies and standards and to industry standards such as AS9100 and NADCAP.
• Review, prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other operational procedures in accordance with the technical specifications, customer's needs
• and requirements, and good manufacturing / engineering practices.
• Define, monitor and report Company’s key performance indicators such as On-Time Delivery, First Pass Yield, Cost of Poor Quality and use these metrics for continuous improvement of Quality.
• Work closely with all departments to meet goal of 100% On-Time Delivery, Zero Defects on all customers’ orders.
• Lead internal team to resolve Quality escalation from customers through systematic root cause analysis frameworks for efficient, effective and timely corrective actions.
• Drive continuous improvement programs such as annual Quality planning, Lean Six Sigma improvement projects, Quality audits, etcetera to achieve Operational Excellence.
• Implement risk assessment systems for all critical control points in the whole quality process flow.
• Implement and maintain a system of auditing the facility and periodic calibration of test, measuring equipment and tools.
• Liaise with vendors on purchase and calibration of production equipment, gauges and Quality consumables.
• Develop and continuously build staff competencies, skills and knowledge through competency gap analysis and team members’ career progression and development plan.
• Identify and integrate relevant QA software into existing quality process flow to increase work efficiency and productivity.
• Support sales team when required by working together to liaise with external customers and stakeholders to deliver timely corrective actions.
• Report to top management on the performance of the quality management system and initiatives towards improvement.

Requirements:

• Minimum Degree in Mechanical / Materials Engineering with minimum 5 years’ experience
• Proven experience as Lead auditee in industry regulations.

Email to: [email protected]

Do visit www.facebook.com/search.personnel and https://www.instagram.com/search.personnel for more job listings and career tips!

***We do not charge our candidates any referral fee nor bind them with any contract.***

Jeslyn Tan

Associate Consulting Director (APAC)

Reg no.: R21101247 | EA No: 13C6684

Thank you for your interest in this position. Our shortlisting period is 3 working days. Only shortlisted candidates will be contacted for further consideration.

If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend that you continue your job search to maximize your opportunities. We wish you all the best and should we have any suitable roles that match your experiences/ qualifications/ preferences, we will reach out to you.

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Key Responsibilities:

The main responsibilities are:

• Pasir Ris Quality Transformation Project: Develop and propose target operations model for Plant Quality Singapore
• Align with QP Bernin future operations model
• Achieve local and global stakeholders alignment and buy in
• Define deployment plan and execute (including management system and reporting)
• Update respective procedures and documentation
• Assess Quality resources: Competencies, HC, performance and propose way forward to fit to the proposed target operations model
• Define training, competency management plan and execute within agreed budget boundaries
• Drive Quality improvement project

Requirements:

• Demonstrating excellent communication and the ability to communicate well with peers and various stakeholders locally and on a remote basis
• Keeping up with a fast paced international company, being resourceful and independant
• You are open-minded and cross cultural agile
• Strong problem-solving skill, independent team player and good interpersonal skills
• Initiative, responsible, and positive attitude
• Meticulous and able to work in a fast-paced environment

• Working Days: 5 days
• Working Hours: Mon to Fri : 8.30am - 5.30pm
• Working Location: East area

Responsibilities

• To lead a team of Engineers to carry out all the Test related activities for Server & Rack products for the production
• To support & implement PXE Server configuration for the products
• Perform & maintain the Server & Rack run-in test process
• Perform & maintain the burn-in & power test process
• To liaise with the customer & HQ / factory on the test program implementation and maintenance
• To test and analyze all failures in the production products and work back with customer & HQ / factory for improvement
• Participate in the Kaizen activities
• To update the test program master list & tracking
• To prepare and update Working Instruction
• To provide training over W/I to production
• To support the NPI Process
• To support production on the mass run
• Participate in ISO activities (implementation & maintenance)

Requirements:

• Minimum 1-2 years of relevant working experience in manufacturing industry/EMS.
• SAP & Linux knowledge
• Good understanding of test methods and concepts
• Knowledge of programming and debugging skills

For consideration, kindly submit your CV by clicking “APPLY Now”.

**Only shortlisted candidate would be notified**

EA Reg. No: R1988238 | Erlynn Tay Kim Geok

Roles & Responsibilities

Cellvec Pte Ltd is currently looking for an experienced & Passionate QA professional who can fully support our clinical and commercial GMP manufacturing of Cell & Gene Therapy Products.

This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:

• Lead a team of QA professionals to manage and oversee all the areas of GMP operations. Always ensure inspection readiness.
• Effectively manage Change controls, Deviations, OOS, QRM, Document management, Trainings, Audits, Batch release, Qualifications & Validations, Business support, Trends & Reports, Annual Product quality review etc
• Supports regulatory and client audits as Quality subject matter expert.
• Provide QA expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations, Qualifications, Environmental monitoring, Risk assessment and specifications.
• Strategize, plan and organise the team's resources to perform operations.
• Plan and develop working knowledge and stakeholder management of the team of Quality professionals.
• Promote the Quality culture on Site through exemplary behaviours.
• Ensures the implementation of adequate training for aseptic gowning, aseptic qualification, practices and QA observations.
• Participates in review of policies and policymaking.
• Ability to communicate quality operations and compliance perspective effectively to senior management.
• Understands and articulates company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.
• Responsibility to drive the focus on safety to the QA staff and into functional areas that routinely support CT/GT manufacturing.
• Any other tasks as and when assigned by the Supervisor.

Ideally, we are looking for candidates with these criteria’s:

• Minimum of Degree in Biochemistry/Microbiology/Biotechnology discipline. Master degree and above are preferred.
• A minimum of 10 years’ experience in the pharmaceutical/Biotech industry, preferably in CGT manufacturing and its GMP compliance.
• Demonstrated experience with helping operations to prepare for Regulatory GMP inspection. Experience managing HSA, USFDA, EU & Client audits are preferred.
• Experience in leading internal, External and regulatory audits. Experience formulating the audit responses and CAPA
• In-depth understanding of cGMP regulations and regulatory requirements of Biotech/Cell and gene industry.
• Strong experience, Extensive knowledge and hands-on experiences of handling Sterile pharmaceutical/Biotech manufacturing processes.
• Ability to apply optimal quality assurance standards to promote a business edge.
• Ability to facilitate business activities compatible to international regulatory environment.
• Ability to communicate effectively within the site organization and across the network.
• Good people management skills.
• Good risk management skills.
• Good Analytical thinking skills.
• Hands on experience in Working with Aseptic environments.
• Exposure in handling Quality Management Systems.
• Exposure in ensuring GLP compliance in QC Laboratory.

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

AVN-Digital is an expert in providing technology enabled business solutions and services. Since inception, AVN-Digital has helped clients Cyber-security, Data Analytics and Robotic Process Automation to improve their operations and profitability, focus on core competencies and achieve business results such as increased agility, innovation and profitable growth. Our in-depth technical knowledge coupled with industry experience and our unique methodologies enable us to successfully deliver and meet our customer’s expectations.

• Proven experience as a Test Manager managing testing lifecycle of 2-3 projects right from planning till project go-live

• Complete understanding of test management activities involving requirement analysis, test design, SIT, UAT, defect management, warranty support

• Excellent skills in managing the testing project timelines and an ability to understand the, overall project deliverables and its possible impact on testing

• Ability to anticipate risks/issues in the testing project and plan the mitigations accordingly

• Ability to craft the Test Strategy and Test Planning at the beginning of the project

• Hands on experience of the test deliverables reporting on daily and weekly basis during the test execution

• Knowledge of defect management through JIRA and test management through Zphyr preferred

• Awareness of the test management metrics and estimation techniques

• Identify, assign and monitor the activities of test specialists in support of the multiple deliverables under their area of responsibility

• Responsible for defect reporting and tracking to project teams, including collaboration on defect resolutions and/or performance deficiencies with developers/partners and identification of retest requirements

• Responsible for metrics gathering and status reporting for project assignment.

Requirements:

• Hands on experience of SQL Scripting/queries and script execution

• Knowledge of the batch runs and test executions

• Preferred to have knowledge of automation using TOSCA, but not a must

• Good understanding of Data ware house and ETL process, Good understanding in SQL / PL SQL and Data base like oracle , Hive

• Participate and drive test automation improvements with tool like TOSCA, Query Surge etc.

Stakeholder Management and Team Management

• Proven ability to manage a team of 5-10 testers in the project.

• Strong domain knowledge of Transaction monitoring apps like ACTMIZE and MANTAS and AML-KYC apps like DETICA(Net Reveal).

• Strong Understanding Actimize framework and its components work together for anti-money laundering and fraud detection (e.g., Enterprise Risk Case Manager (ECRM) , RCM (Risk Case Manager), Suspicious Activity Monitoring (SAM), Customer Due Diligence (CDD) , Watch List Filtering (WLF))

• Good understanding of case management , alert generation , Actimize tool and its workflow

WHAT’S ON OFFER

You will be remunerated with an excellent base salary and entitled to attractive company benefits. Additionally, you will get the opportunity to enjoy a fun and collaborative work environment, alongside a strong career progression.

Privacy Statement: Data collected will be used for recruitment purposes only. Personal data provided will be used strictly in accordance with the relevant data protection law and AVN' privacy policy.

Assistant Manager / Manager, Quality Assurance

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Implement, manage and constantly improve the company’s quality management system, including but not limited to the IVD products and equipment;
• Regularly perform internal audits, compile audit reports, problem analysis reports, improvement proposals, and monitor the rectification plan and its implementation;
• Lead and Participate in the internal audits and management reviews of the company's quality system as key member of company's quality department;
• Manage the system and documents of company’s quality management system, including but not limited to the IVD products and equipment;
• Be specifically responsible for the IVD equipment quality management system;
• Statistical analysis of IVD equipment quality data, and draft reports and corrective and preventive measures;
• Update quality standards, laws and regulations and publish company quality policy;
• Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies;
• Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
• Any other ad-hoc duties or projects as required by the management team.

Qualifications:

• Quality system related training and internal auditor training;
• Familiar with ISO9000 & ISO13485 quality management system and certification work, experience with successful case(s) will be preferred;
• Familiar with GMP and medical device industry standards and specifications;
• Strong quality management system knowledge and capabilities;
• A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (if applicable), along with your current and expected salary to foongying@cordx.com or click to submit here @ My careerfuture.
• We regret that only shortlisted candidates will be contacted

Responsibilities:

• To ensure supply chain processes comply with national regulatory compliance and meet international benchmarks and standards.
• Leads in addressing quality assurance issues in the production department
• Conduct walk by inspections and give real time feedback to team leaders and operators.
• Conduct regular internal audits, surveillance and inspections.
• Complete internal audits on time
• Update Quality manual
• Develop QA plans by conducting hazard analysis, identify Critical Control Points, implement preventive measures, establishing critical limits, monitor procedures, corrective actions and verification procedures.
• Provide advices on and propose in-house quality procedures, standards, and specifications to management.
• To assure consistency in product safety and quality by developing and enforcing Good Manufacturing Practice, validating existing processes, providing documentation and staff management.
• To work closely with Sales, Marketing, and Customer Service Departments to analyse customer complaints and feedbacks, and act as a catalyst for change and improvement in product quality to meet changes in existing customer’s requirements.
• Ensure ISO standards are implemented by all QC Executives (Food Technologist), team leaders and operators.
• To provide leadership and guidance, orientate, train, and guide QC / QA staff and other subordinates on their job.
• Work with Production and QC to establish SOP / WI for use in training staff, like new workers

Requirements:

• At least 3 years and above experience in a similar role in a food production company
• Mastery of FSSC 22000, ISO, HACCP, and Halal standards
• Experience in Food Safety regulatory auditing will be an added advantage
• Self-driven, self-discipline, good team worker
• Self-management (stress management, work organization, time management)
• Willingness and flexibility to work in special projects requiring his/her skills
• Able to communicate fluently in Mandarin and written Chinese

JOB DESCRIPTION:

• Responsible for day-to-day business data management and regular business report preparations, which includes SAP material master maintenance, data integrity checking and statistics.
• Daily monitoring of basic system health and to flag out any inconsistency in API/System functions when found/reported.
• Daily monitoring of system backend jobs and ensure transactional data are interfacing in healthy state with external/internal system.
• To support Business Analytics, extracting and reorganizing original data, dealing with data related issues with other departments.
• Responsible for data preparation, data mining, to create/identify opportunities through analytics, to optimize business objectives.
• Communicate findings and insights to relevant stakeholders in order to assist Manager in making data-driven decisions in KPI assessments.
• Drive continuous improvements /optimization of campaign performance tracking report with business while complying to A*STAR policies.

REQUIREMENTS:

• Bachelor's Degree or Diploma (with at least 5 years or more relevant experience), preferably Business Analytics, Information systems or Computer Science.
• Strong analytical skills, with experience solving problems using data and providing practical business insights.
• Self-Starter with a strong sense of urgency.
• Aptitude to challenge the status quo, think outside the box, and question what has been done.
• Comfortable with dealing with sets of data points from different sources.
• Qualities of matured thinking, dependable and requires minimum supervision.
• Excellent communication skills (oral and written).

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

1. Leadership and Management: Quality Manager requires strong leadership committed to quality improvement. Leaders set the vision, goals, and strategies for TQE implementation, allocate resources, and provide support and guidance to employees.
2. Quality Planning: This involves setting quality objectives, identifying customer requirements, establishing processes to meet those requirements, and developing plans to achieve continuous improvement.
3. Training and Education: Quality Manager emphasizes the importance of training and educating employees at all levels of the organization to ensure they understand quality concepts, tools, and techniques, and can contribute effectively to improvement efforts.
4. Quality Control: Monitoring and measuring processes and outputs to ensure they meet quality standards. This may involve statistical process control, inspections, audits, and other quality control techniques.
5. Quality Improvement: Identifying opportunities for improvement, analyzing root causes of problems, implementing corrective and preventive actions, and continuously striving to enhance processes and products/services.
6. Customer Focus: Understanding customer needs and expectations, gathering feedback, and using it to improve products/services and enhance customer satisfaction.
7. Supplier Management: Working closely with suppliers to ensure they meet quality standards and deliver high-quality inputs, materials, and components.
8. Employee Involvement and Empowerment: Encouraging and empowering employees to participate in quality improvement efforts, share their ideas and suggestions, and take ownership of quality-related activities.
9. Measurement and Analysis: Collecting and analyzing data to track performance, identify trends, measure progress toward quality objectives, and make data-driven decisions.
10. Continuous Improvement: Establishing a culture of continuous improvement where all employees are encouraged to seek opportunities for improvement, experiment with new ideas, and learn from successes and failures.
11. Communication and Collaboration: Facilitating open communication and collaboration across departments and levels of the organization to ensure alignment of quality goals and efforts.
12. Documentation and Documentation Control: Maintaining accurate records of quality-related activities, processes, and outcomes, and ensuring proper documentation control to prevent errors and ensure compliance with quality standards and regulations such as ISO 9001-2015.

The essential responsibilities include:

• Manage, motivate, coach, and develop the Assembly staff.
• Ensure overall adherence to safety practices.
• Review the quality of products including all incoming shipments.
• Performance manage team members, giving direction and feedback to aid good performance
• Check and verify customers' complaints
• Handle customers' product warranty & repair issues via phone calls and emails.
• Fixing and repairing minor defects of products.
• Prepare documents for customer service items to return to retail stores.
• Perform any other tasks as and when assigned

Formal Education & Certification

• Secondary Education or relevant experience

Knowledge & Experience

• Minimum 5 years of relevant experience managing a team in QC setting
  Experience in supervising different shifts
• Proven ability to effectively coach & monitor QC assistants to lead and achieve desired performance goals & objectives
• Good understanding of budgeting and resource allocation
• Experienced in and a desire to lead change and work with others to implement new practices, roles, and structures

Personal Attributes

• Ability to strategically plan for the future, combined with the ability to deliver on details
• A team leader and analytical thinker with strong administrative, decision-making, time management and organizational skills
• Good interpersonal skills – ability to work and interact with all levels of management and stakeholders
• Motivational skills and an ability to supervise and lead a team
• Positive attitude
• Strong problem-solving and conflict-resolution skills
• Ability to work effectively under pressure
• Good active listening skills
• High level of initiative and integrity

Careers that Change Lives

We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.

A Day in the Life

• Leads the QA function to ensure quality system development and compliance with FDA's Quality System Regulation, 13485, MDD / EU MDR, and other quality requirements.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Provides guidance and coaching to all direct reports, includes establishing individual performance & development objectives and plan
• Leads the strategic planning the functional team in driving continual improvement and effectiveness of Quality Operations and Quality Systems.
• Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
• Leads and/or supports initiatives at Medtronic Singapore and across sites to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality; supervise the Quality System implementation. Supports the implementation of engineering projects, including design transfers and provide management oversight in establishing the quality system requirement at other facilities and Medtronic projects.
• Act as the CAPA board chair to ensure effective CAPA process and drive the development of systems and processes for the identification, analysis, correction, and prevention of quality issues.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Works with Singapore and platform leadership team members in developing long and short-term business goals and strategies.
• Represents Singapore on OU/ enterprise Quality Leaders team meeting, collaborate with peers across all sites and Operating Units for global quality initiatives and works closely with peers on similar quality concerns between MDT sites.

Qualifications

Must Have

• Requires a Bachelor’s degree minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

Your Profile

• Minimum of 5 to 7 years management expertise in the Pharmaceutical, Medical Devices or any highly regulated manufacturing industry.
• Overall operational and financial acumen, Business and Project Management skills and experience a plus.
• Familiar with Quality System requirement and knowledge of Quality System Regulations and ISO.
• Broad management knowledge to lead a team and have a prior experience in manufacturing environment and Quality function.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

JJIM aims to cultivate industry-leading capabilities that enhances competitiveness, aligned with HCP needs, and ultimately deliver improved outcomes for patients.

Under this umbrella, the CX& CD CoE aims JJIM to be the preferred partner for HCPs. The vision of this CoE is to deliver industry-leading, data-driven engagement with HCPs that is personalised, orchestrated and seamless across channels. Integrating Content Strategy and Operations closely with Content Approvals is a key enabler. This synergy between content and compliance ensures omnichannel content delivery with the highest quality and speed without compromising risk.

Tasked with the role of improving our content compliance approval workflow, this position will have a significant opportunity to directly drive enterprise growth and efficiency.

*Please note that the role will require 20% travel due to the regional portfolio.*

Key Responsibilities

The Content Compliance Manager will be responsible for supporting the optimized workflow and general management of the copy approval process for advertising and promotional materials and implementing modern practices of approval for content such as claims, components and modular content.

1. Copy Approval Process and Approval Framework:

Enables, advises, and implements risk framework for review and approval of ad/promo materials, claims, components, and modular content in APAC markets. Should be able to significantly reduce time of approval without compromising on risks.

2. Process Implementation:

Ensures optimized workflow is followed in markets with clear adoption plan. Ongoing partnership and communication with Compliant Communications Managers and cross-functional stakeholders (Regulatory, Medical, Legal, HCC, Data Privacy, ITS, Communications, Marketing) in order to achieve business objectives.

3. Technology / system expertise:

Will be expert on copy approval workflow and digital asset management system, provides guidance and support to the current team. Pro-actively collaborate with the business technology team to identify and implement technology optimization for reference, end to end workflow.

4. Cross functional squad delivery teams:

Building, leading and being part of cross-functional teams to deliver on content transformation initiatives. Support the adoption of key initiatives for cross-functional brand teams in the organization.

5. Collaborated with stakeholders beyond APAC:

Collaborate with global and cross-regional teams within JJIM to ensure best practices are identified and transferred to APAC.

Qualifications

At Johnson & Johnson, we value diverse experience, and we look for potential in candidates to move beyond the position they’re hired for. Below is a list of the top 4-5 skills and competencies that are important for this position, which candidates can either bring to this role, or where candidates may be able to learn and grow whilst in the role (this will be dependent on position).

Skills & Competencies

· Content Approvals & Change Management: Ability to lead large scale transformational change in Content approvals.

· Influencing & Stakeholder Management: Ability to influence, drive decisions and outcomes across multiple levels of the organisation, especially with HCC. Ability to work cross-functional teams.

· Strategic thinking and ability to translate strategy into actionable plans: Ability to distill insights into clear strategies aligned to our Vision, translate these into actionable plans (RACI) that drive business outcomes.

· Communication Skills: Excellent verbal, written, visual and facilitation communication skills.

Experience or qualifications that are critical to this position.

· Pharmaceutical experience. Medical, Regulatory or Legal experience, especially in content approvals

· Experience leading workflow optimization

· Understanding of new content practices such as modular content

· Understanding content, and content approvals workflows

· Understanding of approval systems in Veeva promo mats.

· Experience working in an Agile environment (desirable)

Job Descriptions

- Perform hands on pest control work on customers' sites

• Attend to Clients' complaints on pest issues and understand the potential causes of pests' activities

• Conduct on-site routine reviews to Client's premises to check on the quality of the technical team and ensure Company's SOP and Protocol are followed thru' by technicians.

• Prepare ad-hoc / monthly formal reports to clients with recommendations for remedial actions for enhanced protection of their premises.

• Attend meetings with technical team as well as NEA inspectors on site.

• Do presentations during meetings in front of customers/NEA officers to review pest issues

• Implement on work plan, Risk Assessment, Safe Work Procedures, hygiene standards to ensure compliance with Workplace Safety & Health Environment.

• Maintain mandatory records and other documentations for Bizsafe Level 3 Certification.

• Strong knowledge on General pests & safety regulations will be an added advantage.

• Proficient in MS Office.

• Ability to lead

• Good command of English

• Minimum 4 years experience in the relevant field.

• NEA Pest Management Licence preferred

• Must have Class 3 driving licence

• Able to start work immediately or short notice.

• Must be prepared to be on standby duty 24/7 even on weekends or public holidays

Job Summary :

We are looking for a Test Program Manager :

Requirements:

• 20 years of experiences in Banking Domain
• Experiences in Test Program Management Skills
• Experience in Investment Banking, Wealth Management Domain
• Experience in Temenos T24 Implementation Testing
• Excellent Communication and Stakeholder Management Skills

Qualification:

• Degree in related Discipline