As a Motion Control Engineer of Halliburton Wireline Technology team, under broad guidance, you will be responsible for Motion Control firmware design and development of new product and enhancements, verify and validate firmware through integrated testing at module, product and system levels. You’ll also be involved in field testing support, manufacturing release roll-outs of the new products.

Job Roles

- Analyse system & subsystem motion control requirements, identify firmware features, break down task lists and provide schedule estimations.

- Lead and implement board level firmware development, debugging and testing activities including algorithm, communication, and system firmware development.

- Participate in board, product and system level product integration, verification and validation. You’ll be working with multi-discipline function test members onsite and/or offsite proactively and positively to achieve smooth development progression and effectively issue resolutions.

- Document firmware design and qualification reports as per compliance requirements and fulfilling project life cycle gate reviews.

- Support manufacturing production in firmware related activities.

Job Requirements

- Electrical/electronic degree or equivalent.

- Minimum 2 firmware hands on experience with C/C++/Assembly programming.

- Familiar with DSP/MCU microprocessor architectures. Experience on peripheral driver development like SPI, I2C, UART, etc.

- Hands-on experienced at least one product cycle of implementing PMSM/BLDC control.

- Knowledgeable in using laboratory equipment that is used for control system debugging and verification.

- Experience on data acquisition with on-board ADC/DACs.

- Communication protocol development experience with bus like CAN, 1553 and Ethernet is added advantages.

- RTOS experience will be a good plus.

- Experience on digital signal processing for application like digital communication is an added plus.

- Matlab/Simulink – Embedded Coder for automatic code generation is an added plus.

Self-initiative, independent and a good team player

Job Description

- Responsible for coordination, execution, and implementation of key microbiology and food safety programs for the site, including Raw Material Sampling Plan , Finished Product Sampling Plan, Environmental Monitoring and other food safety initiatives and certifications,.

- Ensure all products produced at this site meet all local and federal regulations and is safe and wholesome

Job Requirements

- Ensure GMP and food safety requirements and policies are implemented and respected

- Develop , implement, maintain and coordinate food safety programs (FSSC22000, HACCP,

Environmental Monitoring, Pest Management, Raw material and Finished Products

Sampling Plan) for the production facility

- Support the implementation of corrective actions associated with identified gaps (both internal and external)

- Ensure data is entered into the Quality documents accurately and in a timely manner

- Work closely with Supply Chain to ensure incoming ingredients, chemicals and packaging materials are sampled, inspected, and approved for use in the plant

- Lead third party and internal audits and their preparation and follow up (FSC22000,Customer and Regulatory)

- Provide support to correct key food safety complaints

- Ensure processing techniques and SOPs in the production are being followed

- Identify risk in production area, review safe work routine and ensure it is well implemented

- Quality assessment of in-process and finished products

- Ensure the plant is always compliant with company and legal procedures and policies

- Ensure the plant quality and food safety systems are always ready for an audit

- Committed to ensuring that the products produced meet all food safety and quality requirements

Job Description

• Act as backup for GPS monitoring and preparation of GPS report
• Act as backup for CCTV monitoring and preparation of input into the CCTV monitoring reports and coordinate between the operations team
• Attend all other various periodic meetings and audit requirements of all oil majors
• Attend and assist ISO preparation and audits
• Attend all incident investigations and coordinate recommendations, suggestions and closure
• Coordinate and prepare monthly closing reports of all oil majors
• Coordinate and manage all safety meetings, toolbox meetings and other various paperwork
• Coordinate and ensure gap closure arising from various audits
• Ensure up to date keeping of all oil majors, operations and management systems
• Plan, organize and support all company’s safety programme, campaigns and events.
• Other ad hoc duties as assigned by your supervisor

Requirements:

• Proficient in Microsoft Office
• Strong communication and interpersonal skills
• Graduates without experience are welcome to apply as on job training will be provided

Working location:

Joo Koon

Working hours:

Mon - Fri 8.30am to 5.30pm &

Sat 8.30am to 12.30pm

Please contact 8820*9727 for more details.

We regret that only shortlisted applicants will be notified

Role:

A Quality Assurance Manager at HOPE Technik will play a crucial role in ensuring the highest standards of quality for robotics, automation, and special vehicle projects. This individual will be responsible for leading and developing the Quality team, implementing quality assurance policies, and continuously improving processes to meet and exceed industry standards.

Key Responsibilities:

1. Team Leadership and Development: Build, train, and lead a team of quality assurance specialists.
   Foster a culture of continuous improvement and learning within the team.
   Conduct performance reviews and facilitate professional development opportunities.
   
2. Quality Assurance Strategy and Implementation: Develop and implement quality assurance policies and procedures.
   Collaborate with engineering and project management teams to integrate quality assurance into all phases of the development lifecycle.
   Ensure quality objectives are met by setting, monitoring, and enforcing standards and protocols.
   
3. Project Support and Quality Control: Provide expert guidance and support in quality planning for new projects, particularly in robotics, automation, and special vehicles.
   Oversee the inspection and testing of products to ensure adherence to established quality standards.
   Directly manage critical issues with product quality, providing immediate corrective actions and long-term solutions.
   
4. Continuous Improvement: Regularly review and analyze quality data and feedback to identify trends and areas for improvement.
   Implement innovative solutions and quality improvement practices.
   Stay informed of the latest industry trends, technologies, and quality assurance methodologies.
   
5. Compliance and Documentation: Ensure all quality assurance activities comply with industry regulations and standards.
   Maintain comprehensive documentation of quality assurance activities, tests, and outcomes for accountability and continuous learning.
   
6. Stakeholder Engagement: Communicate effectively with all levels of the organization, including senior management, engineering teams, and project managers.
   Build relationships with suppliers and external partners to ensure quality standards are understood and met.
   

Qualifications:

• Bachelor's or master's degree in Engineering, Quality Management, or a related field.
• Proven experience in quality assurance, preferably in the fields of robotics, automation, or vehicle engineering.
• Strong leadership skills with experience building and managing teams.
• Excellent problem-solving, organizational, and communication skills.
• Knowledge of quality assurance methodologies, tools, and regulations.
• Certification in Quality Management (e.g., CQM, CQE) is a plus.

Tuas and Biopolis, Singapore

ScaleUp Bio is seeking a highly skilled and experienced Quality System Specialist/ Assistant Manager to join our team. The Quality System Specialist/ Assistant Manager will be responsible for establishing and maintaining quality / food safety related systems. These can include document control, change control management , customer complaint, and various audits. The successful candidate will cover both of our facilities at Biopolis (Singapore) and Tuas (Singapore), and will be reporting to the QA/QC Manager.

Your Responsibilities:

• Assist QA Manager in the implementation of food safety and quality systems, actively participate in food safety efforts and ensure all activities conform to good manufacturing practices.
• Manage, plan, implement, and continuously improve the Food Safety/Quality programs in the Scaleup Bio facilities.
• Serve as the Food Safety Team member and is actively involved in all HACCP Plans.
• Responsible for management of the Supplier Programs including complaints management and feedback.
• Manage the conduct of local supplier audits to ensure that suppliers are qualified.
• Lead Change Control Management.
• Manage Document Control Program
• Manage the local Mock Recall exercise
• Assist QA Manager in crisis situations, such as a potential product recall, high profile customer complaint.
• Set up, implement, and maintain HALAL Assurance System. Main liaison with MUIS (Majlis Ugama Islam Singapura).
• Manage the conduct of internal audit program and ensure compliance to requirements of GMP / HACCP pre-requisite programs, Quality systems, Halal assurance system.
• Assist QA Manager to prepare for external audits and ensure agreed audit findings are corrected and preventive measures are put in place.
• Manage the customer complaint handling system – evaluation, investigation and corrective/preventive action planning, implementation and monitoring.
• Work with multi-disciplinary teams to ensure the progress timeline.
• Ensure safe working practice in research labs, pilot plants, and manufacturing facilities to meet or exceed safety goals.
• Any other tasks related to quality system, as assigned by QA Manager.

Your Profile:

• Bachelor degree with 5+ years’ experience or equivalent in Food Science / Food Technology or related field.
• Industrial experience is desired
• Experience in setting up quality system and food safety system in food industry.
• Trained in HACCP/ FSSC 22000 internal audit.
• Lead auditor certification would be a plus.
• Familiarity with microbial communities and fermentation process would be a plus.
• Strong communication and organization skills, be able to multi-task and exhibit a strong sense of urgency in order to accomplish daily tasks.
• Be self-motivated with the ability to manage time and priorities; must be able to work independently in a team environment, maintain a positive attitude
• Strong writing skills and be fluent in English.

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Job Overview:

• Perform routine and ad-hoc environmental monitoring (EM) of critical utilities such as HVAC/BSC/VLFH/HLFH, water systems, compressed air/gas system and personnel monitoring
• Lab testing of EM samples in accordance with cGMP regulations and Roche/Genentech standards.
• Support manufacturing operations by timely completion of testing and disposition.

Key Responsibilities:

Technical and Functional:

• Perform EM which includes HVAC/BSC/VLFH/HLFH monitoring, compressed gas, personnel monitoring, water and clean steam sampling in accordance to cGMP procedures.
• Perform testing and review of routine and non-routine environmental monitoring samples in accordance to the Standard Operating Procedures (SOP).
• Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
• Prepare EM trend graph periodically for trend data analysis.
• Operate laboratory autoclave and EM testing equipment.
• General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.
• Perform daily checks in EM LIMS to ensure all assigned EM tasks are completed and/or tested on time.
• Initiate discrepancy record for EM action excursion, adverse trend and/or discrepant event.
• Carry out assignments / projects given by Supervisor. Deliver results per plans / schedules.
• Communicate all problems / issues timely to Supervisor.
• Suggest improvements to streamline / facilitate workflows.
• Participate in internal / external audits and regulatory inspections.
• Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
• Monitor and keep track of inventory stocks for laboratory consumables and items required.
• Perform sample receipt and storage of QC samples.

Leadership:

• Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team’s objectives / goals, takes the initiative and proactively turn ideas into action – to make things happen.
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
• Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
• A team player and the willingness to cover other colleagues in continued support of the Micro / EM operations.

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Key Interfaces:

• Other QC functions
• FEES / Utilities
• Manufacturing
• Warehouse
• Safety, Health and Environmental (SHE)

Qualifications:

Education

• Bachelor’s degree in a relevant science field or equivalent

Knowledge / Skills / Competencies:

• Demonstrate good verbal and written communication skills in English
• Independent, reliable and collaborative team player
• Able to follow written procedures.

Prepared to work overtime on weekday(s), weekend and/or Public Holiday and willing to perform shift duty if required

What’s it all about?

The Escalations and Compliance Manager is a key part of Currencycloud's second line compliance function, reporting directly into the Head of Compliance APAC. The Escalations and Compliance Manager will be the primary escalation point for high-risk clients and transactions, as well as making risk appetite decisions impacting Currencycloud in the APAC region. They will work closely with colleagues in the first line of defence to provide coaching and guidance to junior team members, as well as supporting projects that enhance Currencycloud’s financial crime control framework.

What we expect of you, day to day:

• Make judgements on escalations from compliance operations teams such as sanctions alerts, other high risk transactions and applications involving politically exposed persons. 
• Where necessary, schedule sessions to present specific cases to senior stakeholders such as the Head of Compliance APAC. 
• Deliver formal and informal training on corner cases, changes in risk appetite, and new policies/procedures to the compliance operations team. 
• Provide regular coaching and guidance to junior team members on specific cases that have been escalated. 
• Build and maintain relationships with the go to market organisation to understand emerging opportunities and market developments that may requires changes to Currencycloud’s financial crime control framework.
• Contribute to the ongoing enhancement of the overall financial crime framework by identifying new typologies and potential gaps in existing policies and procedures. 
• Support the Head of Compliance APAC in updating existing policy documents completing the annual risk assessment.
• Support the Head of Compliance APAC on projects to enhance Currencycloud’s financial crime framework, including new processes and system implementation. 
• Maintain an excellent technical knowledge of financial crime regulations, keeping up to speed with new developments and the latest regulatory positions of key markets that Currencycloud operates in.
• Be aware of changes in the wider business (products, jurisdictions etc.) and how these may impact the compliance operations team.

The successful incumbent will be part of a group of individuals who will assist and support the wider Risk & Compliance framework within the Asia cluster, actively ensuring timely compliance with external and internal regulations to actively control and manage operational, regulatory, and reputational risks.

Part of your scope will include:

• Project Lead for a robust but proportionate structured Ongoing Client Screening Programme
• Project Lead for a KYC Remediation Programme for client serviced entities in Singapore and Hong Kong

Additionally, you will be required to collaborate and provide assistance and support for the
implementation of projects undertaken by the Risk & Compliance Team. This includes providing timely reports on projects to ensure necessary stakeholders are kept informed, actively participating in alignments with the Risk & Compliance initiatives and acting as POC for assigned projects.

You are expected to support on all aspects of regulatory and compliance requirements, stay informed of regulatory developments on the prevention of Anti-Money Laundering/Countering the Financing of Terrorism (AML/CFT), assessing potential impact on the Company’s existing policies and procedures and implementing changes and enhancements to the Company’s internal control environment and risk framework to ensure compliance with regulatory and group standards.

In carrying out your role, you may be required to get involved in the following:

• Developing and executing a robust but proportionate structured Compliance Monitoring Programme
• Promoting and supporting an effective Compliance culture, through:

1. Identifying, monitoring and reporting regulatory risk within the business. To facilitate this all
2. regulation and guidance that is applicable to the entity must be recognised and documented.
3. Changes in regulation must also be identified and analysed in a timely manner;
4. Ensuring that applicable Compliance policies and procedures are kept up to date for changes in regulations and in regulatory expectations and that management and staff are kept apprised of such changes;
5. Keeping in close contact with the business and senior management, in order to be able to identify and advise on any compliance issues in a proactive and timely manner, ideally at the “embryonic phase” of business development;
6. Providing regulatory advice and guidance to the First Line (both client-specific and in respect of broader business initiatives) to ensure that regulatory compliance is maintained;
7. Assisting the operational areas to identify and embed key compliance related controls, including policies and procedures. Providing guidance on the proper application and interpretation of laws, regulations and policies applicable;
8. Reporting to the Board, GRC and other relevant stakeholders on a periodic basis and advising them of key regulatory risks emerging within the business in a formal context through the
9. production of Management Information ("MI"), KRIs or other standard reports;
10. Escalating, managing and reporting significant legislative breaches in an independent and
11. appropriate manner; and
12. Running training sessions on compliance-related matters to improve compliance awareness amongst First Line staff; and
13. Participating, as agreed, in Group and Local governance and oversight forums – e.g.
14. Acceptance, Continuation and Exit Committee (ACE), Country Risk & Compliance Committee (CRACC) etc.

1. Perform inspection, testing and sampling of material or assembled parts or products for defects and deviations from specifications.
2. Observe and monitor production operations and equipment to ensure conformance to specifications and make or order necessary process or assembly adjustments.
3. Report and Discuss inspection results with those responsible for products and recommend necessary corrective actions.
4. Issue NCR to materials and equipments that fail to meet material specifications.
5. Maintain records from testing, information and various metrics for tabulation of results
6. Inspect production cycle to ensure production is efficient and comply with safety standards
7. Prepare reports and logs, summarizing re-work and waste and input information to quality database
8. NCR data collections and photo taking.
9. Ensure calibrated equipments and logs are maintained and bring calibrated.

Requirements

• Preferably with related working experience.
• Minimum O’level or equivalent qualifications
• Proficiency in English and adequate computer skills.

4e, a leading financial company, is seeking an AML Compliance Analyst to join their team. As an AML Compliance Analyst, you will be responsible for ensuring that the company complies with all anti-money laundering regulations. You will conduct investigations, monitor transactions, and identify any potential money laundering activities.

Responsibilities:

• Conduct on boarding and ongoing customer due diligence, including verification of the KYC documents, name screening, and client risk assessment.
• Conduct and perform quality check on transaction and wallet screening.
• Assist to conduct the investigation on suspicious activity, sanctions, and enhanced due diligence.
• Handle daily KYC and transaction enquiries from business teams and relevant stakeholders.
• Assist to prepare internal reports.
• Assist with maintenance of AML program documentations, including KYC documents and reporting recordkeeping, etc
• Perform ad-hoc tasks as assigned
• Keeping abreast of regulatory developments, including global AML/CFT rules and regulations

• Bachelor's Degree in Finance, Accounting, Law or relevant studies
• Knowledge or experience in virtual assets / digital currency is a plus
• At least 2 years of relevant working experience in the AML field
• Familiar with AMLO, or AML related laws and regulations
• A detail-oriented and a self-started person
• Good interpersonal and communication skills
• Experience in Microsoft Office pack

We are currently seeking Mobile Testers based in Singapore City. As a Mobile Tester, you will be responsible for testing mobile applications and ensuring their functionality, usability, and performance on various devices and platforms.

• 3+ years of experience in mobile testing
• Strong knowledge of mobile testing methodologies and best practices
• Experience in manual testing of mobile applications on iOS and Android platforms
• Experience with mobile automation testing tools such as Appium or Espresso
• Understanding of Agile methodologies and experience working in Agile development environments
• Knowledge of mobile app performance testing and optimization
• Strong problem-solving and debugging skills
• Excellent communication and collaboration skills

About Us

Zone IT Solutions is Australia based Recruitment Company. We specialize in Digital, ERP and larger IT Services. We offer flexible, efficient and collaborative solutions to any organization that requires IT, experts. Our agile, agnostic and flexible solutions will help you source the IT Expertise you need. Our delivery Offices are in Melbourne, Sydney and India. If you are looking for new opportunities your profile at [email protected] or contact us at 0434189909

Also follow our LinkedIn page for new job opportunities and more.

Zone IT Solutions is an equal opportunity employer and our recruitment process focuses on essential skills and abilities. We welcome applicants from a diverse range of backgrounds, including Aboriginal and Torres Strait Islander peoples, people from culturally and linguistically diverse (CALD) backgrounds and people with disabilities.

Pfizer Singapore is recruiting permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. Your knowledge of quality control will be helpful to support our quality programs. Your ability to analyze chemical, biological or microbiological products will help us manage our quality. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to its patients.

Your qualifications of unique Quality Control instruments will help us meet accuracy specifications for sample management, retains managements, interpretation and evaluation. You will also be relied on for establishing requirements for the transfer of methodology from R&D.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Perfrom Analytical Method Transfer, Analytical Method Validation and Analytical Method verification in accordance to Standard Operating Procedures (SOPs).
• Perfrom Cleaning Method Development and Validation.
• Perfrom the impact assessment to products based on compendial monograph changes/updates/introduction.
• Perfrom and review the regulatory submission and support for queries.
• Perfrom Laboratory Investigation.
• Support to QC Method trouble shooting.
• Ensure training records are updated and correctly filed to reflect current testing capabilities and train the colleagues in hand on training of instrument and method written.
• Perform sampling and labeling of materials as per defined procedure and verification of all the equipment / instruments.
• Review, write and approve the position paper, protocols, reports, and test procedure.
• Interpret and evaluate data in terms of accuracy, precision, trends and potential Good Manufacturing Practices {also cGMP} impact and recommend appropriate corrective actions.
• Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices and Good Laboratory Practices requirements and that they are filed in accordance to existing policies.
• Review and revise Standard Operating Procedures (SOPs), analytical methods and related procedures/documents, to keep them current.
• Perform analyses on finished products, raw materials, and components including entry, review, and/or approval of data in a computerized database and generate EMS reports.
• Conduct Microbiological protocols on an as needed basis.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Qualifications

Must-Have

• Bachelor's Degree
• Demonstrated technical skills in method transfer, method validation and testing
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
• Knowledge of Good Manufacturing Practices and its application standards, processes and policies
• Excellent organizational skills and strong ability to multi-task
• Strong written and verbal communication skills

Nice-to-Have

• Laboratory work experience with chromatographic techniques like HPLC (High Pressure Liquid Chromotography) technique and GC(Gas Chromatogrphy ) technique and all other analytical techniques use in the laboratory.
• Experience leading continuous improvement projects
• Knowledge of lean manufacturing, six sigma methodologies, and statistics

Position Summary

The incumbent will be responsible for overall management of the Quality Control (QC) Laboratory services and their related support teams. With extensive knowledge of compliance requirements relating to the QC function together with excellent verbal, written, and interpersonal communication skills the incumbent will need to be action-orientated, agile with respect to change management and a strong leader for the quality culture of the Laboratory and the site to achieve the site Quality Control operational objectives. Key accountabilities include:

• Lead, coach and develop a team of QC Managers, supervisors and their related laboratory teams ensuring that analytical (physical, chemical and microbiological) testing, data review activities and Laboratory equipment and systems on site comply with site Standard Operating Procedures (SOPs) and are performed in a safe and reliable manner to support manufacturing operations at the site and across all shifts.
• Ensure that the quality systems in the Laboratory are continually audited with new requirements implemented and all QC related operations comply with Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards (PQS).
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

Responsibilities:

• Responsible for developing and managing integrated Quality Systems and providing technical support and advice on Quality Control matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Development.
• Responsibility of setting up and implementing QC Laboratory quality systems and strategies for developing and implementing monitoring systems to collect, collate and present information on Quality Control Laboratory for performance management and bench marking. This includes review and approval of Standard Operating Procedures (SOPs) and periodic review processes.
• Responsibility for QC personnel management, QC project management, and ensuring that quality risks associated with the QC Laboratory operations are correctly assessed, identified and managed.
• Plan and track Quality Control objectives, timelines, priorities, and resources.
• Develop, write and present business cases for equipment, staff resources and service developments.
• Manage and ensure the provision of chemical and microbiological analytical services to internal/external customers to ensure that all starting materials/water samples/intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements so as to provide accurate test results for correct GMP usage decisions.
• Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
• Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. Perform investigation related to EHS (as needed).
• Ensure that the laboratory equipment are qualified to meet regulatory standards, well maintained and in good working order.
• Work closely with the relevant process owners (i.e. Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting material sources.
• Manage and provide oversight of the strategy and execution of Analytical Method Transfer Exercise (AMTE) from other Pfizer sites and Centre functions for new products introduced to the site. This involves the development / validation / verfication of new /existing analytical methods for testing starting materials, process intermediates, APIs and plant cleaning samples.
• Lead and/or contribute to the implementation of the site and corporate projects in line with specifications and budget allocation.
• Promote use of Right First Time (RFT) methodologies and root cause analysis tools for analytical trouble shooting, safety and Continuous Improvement Projects (CIP). Using Statistical Process Control (SPC) methodologies for improving efficiencies and cost.
• Ensure the product stability programs are managed and testing data (including stability data) is reported for Annual Product Review Reports (APRRs) and regulatory filing in a timely manner.
• Ensure laboratory automation is functional at all times and supports laboratory efficiency.
• Support, promote and demonstrate Pfizer Global Supply (PGS) vision, values and leader behaviors.
• Manage, develop, and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.
• Uphold Pfizer's code of conduct and values.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.
• Collaborate with cross-functional teams to drive flawless execution.
• Fulfil requirements of a first line leader (FLL) as described in site procedure that includes (but is not limited to) the below:
• Engage and inspire team on performance expectations and coach the team to meet expectations using Coaching Skills principles
• Effectively monitor the actions of team members. Ensure presence in the GMP work area to observe work activity and practices.
• Be available for direct report(s) for real time escalation of any concerns or support needs
• Be accountable for Good Data Management and Data Integrity understanding and performance of the team
• Be a role model to support a positive compliance culture
• Be vigilant for potential actions or behaviour that could result in breaches of GMP compliance or Data Integrity principles

Job Related Requirements:

• Effective problem solving skills.
• Demonstrated leadership, management and customer service skills.
• Excellent verbal, written and interpersonal communication and presentation skills.
• Demonstrated ability to interact effectively with senior management, auditors and regulators.
• Strong knowledge of analytical chemistry, analytical method validation, instrumentation, laboratory automation and production processes.
• Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories.
• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment, experience in Empower software.
• Knowledge of six sigma, lean labs and standard work practices.
• Possess a can-do / pride to succeed attitude and be a positive influencer/role model.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Education

Bachelor or Master or Ph.D. degree in Science (Chemistry preferred) or Life Sciences relating to Chemistry, Pharmacy, Pharmaceutical Sciences or Microbiology or a related science.

Experience

• Minimum 8-10 years of technical experience in Quality Control within the pharmaceutical, food, chemical or process industries. Additional experience in Quality Assurance is highly desirable.
• Minimum 5 years in a leadership/supervisory position of professional staff previously, or demonstrated capability to successfully lead large teams.
• Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories.
• Experience in an API manufacturing plant is preferred.
• Effectively communicate through written and oral means, demonstrated ability to interact effectively with senior management, auditors and regulators.

The incumbent will have the following core competencies:

• Project Management skills
• Team Leadership skills
• Communication skills
• Analytical skills
• OPEX skills

Responsibilities

• Responsible for the API, ISO and Safety certification program for the Group as Management Representative.

• Monitor the assembling, swaging, production, test & inspection of hoses to API Q1 and API Spec 7K standards.

• Conduct quality audits of product/materials compliance with API Spec Q1 and API Spec 7K.

• Prepare, document and implement API Spec Q1 & API Spec 7K, requirements and compliance.

• Conduct and supervise QA & QC inspection and testing.

• Research, prepare, specify and document all the necessary QA/QC manuals, procedures, inspection, testing process, risk assessments SOPs and work instruction relating to QA/QC activities and control.

• Provide accurate, reliable and prompt quality data by conducting tests/inspection on conformance to company protocols & methods, QA/ QC sampling regime and API Spec Q1 & API Spec 7K guidelines and requirements.

• Perform planned maintenance & calibration of QA/QC equipment to ensure accurate and optimal performance.

• Perform supplier quality audit and maintain quality performance.

• Coordinate and control the NDE by 3rd party inspectors including reviewing the NDE procedures and reports from 3rd party agency

• Monitor and update the QMS as per the latest edition of applicable systems and products standards.

• Perform Internal Audits and Chair the Management Review Meetings.

• With QMS experience in Semiconductor Industry.

• Any other ad-hoc duties as assigned

COMPANY DESCRIPTION

REC Group is an international pioneering solar energy company dedicated to empowering consumers with clean, affordable solar power through high-quality solar panels with a leading power density. As Solars Most Trusted, REC is known for its patented innovations and multiple award-winning products with reliable long-term performance. The cornerstone for RECs strong reliability is advanced and highly efficient manufacturing using Industry 4.0 practices. Founded in 1996 in Norway, REC has always been committed to a low carbon footprint in its solar materials and panels. REC is headquartered in Norway with operational headquarters in Singapore and regional hubs in North America, Europe, and Asia-Pacific. As of December 2021, REC is part of Reliance Industries Limited, Indias largest private sector company with revenues of USD 104.6 billion.

Find out more at recgroup.com

RESPONSIBILITIES

• Drive customer issue resolution activities following the claims management process, i.e. root cause analysis, containment, corrective action, and factory process / quality controls improvements to prevent recurrence of problems and efficacies of detection.
• Process field claims in a timely manner for resolution.
• Work with regional Technical Product Managers to resolve field claims. This includes performing failure analysis and field visits to customer sites/installation.
• Providing timely engineering insights including failure analysis technical reports and presentation.
• Analyze product warranty claim and provide modeling on product service life.
• Collaborate with cross functional teams, contributing to the domain of product FA or characterization.
• Handles customer visits and factory audits and product inspection.
• Develop & contribute to building knowledge base of degradation from product to material level.
• Design tests to detect infant mortality and mid-life product failures.
• Perform investigation including product reliability data analysis, and modeling product performance behavior to identify opportunities in future development or continuous improvements for current technology.

• Bach / Masters / Phd Degree in Engineering or Science (Electrical, Mechanical, Physical Sciences)

REQUIRED SKILLS

• Problem-solving, failure analysis and trouble-shooting, statistical data analysis and design of experiment
• Application experience in managing (large) data modelling would be favorable
• Excellent practical knowledge and use of Microsoft Office
• Excellent interpersonal skills, strong belief in driving for quality and customer satisfaction.
• Ability to interface and communicate effectively with cross-functional teams as well as external stake holders and external auditors.
• Communicate effectively through presentation and technical reports.
• Enjoys rigors of technical reviews with peers & management to drive to business outcome.

Pfizer Singapore is recruiting permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. Your knowledge of quality control will be helpful to support our quality programs. Your ability to analyze chemical, biological or microbiological products will help us manage our quality. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to its patients.

Your qualifications of unique Quality Control instruments will help us meet accuracy specifications for sample management, retains managements, interpretation and evaluation. You will also be relied on for establishing requirements for the transfer of methodology from R&D.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Perfrom Analytical Method Transfer, Analytical Method Validation and Analytical Method verification in accordance to Standard Operating Procedures (SOPs).
• Perfrom Cleaning Method Development and Validation.
• Perfrom the impact assessment to products based on compendial monograph changes/updates/introduction.
• Perfrom and review the regulatory submission and support for queries.
• Perfrom Laboratory Investigation.
• Support to QC Method trouble shooting.
• Ensure training records are updated and correctly filed to reflect current testing capabilities and train the colleagues in hand on training of instrument and method written.
• Perform sampling and labeling of materials as per defined procedure and verification of all the equipment / instruments.
• Review, write and approve the position paper, protocols, reports, and test procedure.
• Interpret and evaluate data in terms of accuracy, precision, trends and potential Good Manufacturing Practices {also cGMP} impact and recommend appropriate corrective actions.
• Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices and Good Laboratory Practices requirements and that they are filed in accordance to existing policies.
• Review and revise Standard Operating Procedures (SOPs), analytical methods and related procedures/documents, to keep them current.
• Perform analyses on finished products, raw materials, and components including entry, review, and/or approval of data in a computerized database and generate EMS reports.
• Conduct Microbiological protocols on an as needed basis.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Qualifications

Must-Have

• Bachelor's Degree
• Demonstrated technical skills in method transfer, method validation and testing
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
• Knowledge of Good Manufacturing Practices and its application standards, processes and policies
• Excellent organizational skills and strong ability to multi-task
• Strong written and verbal communication skills

Nice-to-Have

• Laboratory work experience with chromatographic techniques like HPLC (High Pressure Liquid Chromotography) technique and GC(Gas Chromatogrphy ) technique and all other analytical techniques use in the laboratory.
• Experience leading continuous improvement projects
• Knowledge of lean manufacturing, six sigma methodologies, and statistics