• Responsible for the maintenance and engineering of all process control systems which may be installed in the plant or externally at customers' site.
• Perform fine-tuning, troubleshooting, modification and programming of the Control System as needed to improve system performance and optimize process operation needs.
• Response to 24-hour emergency call-out and provide night-shift support during plant startup, shutdown and as requested by Operation Team.
• Work closely with the Instrument Team to troubleshoot and resolve instrumentation problems.
• Work with the Project Team to develop requirements and/or specifications of control system for projects and modifications; supervise & implement the project works according to the schedule and requirements.
• Plan and execute preventive and corrective maintenance works for plant turnaround.
• Perform strategy planning for control system expansion, upgrading and renewal.

Job Requirements

• Degree in Electronics/Electrical Engineering, major in control and instrumentation is preferred.
• Minimum 5 years of experience working and maintaining process control systems, especially
• Honeywell DCS, Siemens PCS7 and Triconex PLC. Familiar with the engineering tools and programming languages of these systems.
• 3-5 years working experience in the refinery or petrochemical industry environment.
• Experience and knowledge in field instrumentation and control valve are added advantage.
• Experience in control system expansion, upgrading and renewal projects.
• Self-confident and able to work independently with minimum supervision but also a good team
• layer.
• Able to multitask, perform well under high pressure and quick-changing environments.
• Familiar with Microsoft Office, Project, Outlook and SAP systems.
• Knowledge and experience with computer system networking and server/client environments.
• Good analytical, troubleshooting and problem solving skills.
• Good written and communication skill.

Job Scope:

• Perform the role of Lead Investigator into incidents to which you have been assigned. In doing so, it is necessary to immediately:
  • Visit the area where the incident has been detected (if applicable, e.g. if detected internally in an operational setting)
  • Discuss with all involved in the incident to gain a full understanding of the process and incident per GQA.003
  • Gather background information (or coordinate accordingly) regarding the reported incident
• Perform an initial impact assessment in a timely manner. Identify immediate action to be taken in order to ‘ring-fence’ the problem and ensure it is not further exacerbated whilst the investigation is ongoing.
• Liaise with personnel within various departments / sites and encourage individuals to be forthcoming with pertinent information to facilitate the investigation. This may involve Lead Investigators in other areas or at other sites.
• Host internal meetings (locally or globally, as applicable) and co-ordinate brain-storming sessions to advance the investigation.
• Use appropriate Root Cause Analysis tools (as applicable) to establish causes and any contributory factors.
• Determine the communication strategy and effectively liaise with the PL /PM (as applicable) and all other relevant parties to appraise them of the investigation as it progresses (where applicable). This may extend to include notification of customers, VPs, Key Account sponsors, BD, Commercial Contracts, Quality Management and the QPs (as applicable).
• Escalate to department manager and Quality management any critical issues that become apparent during the course of the investigation that may not have been immediately obvious.
• Determine appropriate and meaningful CAPA to prevent recurrence. Gain agreement of such with department managers (locally or globally, as applicable).
• Document the investigation in the appropriate template. Ensure the report is written to a high standard and that every effort is made to ensure it is Right First Time and acceptable to the customer and the regulators.
• Proactively monitor the progress of all investigations assigned to you and prioritise accordingly. Take responsibility and ownership for such endeavoring to ensure close out in a timely manner. Escalate any that are overdue.
• Perform CAPA effectiveness checks as required in a timely manner and provide the necessary evidence of such to Quality.
• Host or participate (as applicable) in external teleconferences / meetings / regulatory inspections to discuss particular incidents, should additional explanation or assurance be needed. Ensure all such contact, oral and written, is carried out professionally in order to develop and maintain good relationships.
• Promote good inter-departmental and global relationships. Work within and across functions and sites as necessary to assure global consideration of investigations and the CAPA arising from such.
• Endeavor to approach problems with a positive attitude and as an opportunity for company to continuously improve.
• Attend all necessary training and retain a thorough knowledge of processes / procedures pertinent to the area you represent.
• Update KPIs and capture trending information at a department level, ensuring there is good visibility of this data globally. Remain observant of recurring issues, taking such into consideration at the point of an investigation and escalate to management as applicable.
• Meet regularly with management to discuss KPI and trending data. Present ideas / suggestions for consideration into further process improvements.
• Attend periodic meetings with other Lead Investigators locally and globally. Be forthcoming with ideas / experiences to ensure shared learning and continuous improvement.
• Ensure documentation is generated and completed in accordance with the principles of GMP and internal SOPs.
• Fulfil any necessary duties associated with the role, as and when required.

Requirement

• Has prior QA background with focus on report generation and reviews
• Able to engage multiple stakeholders independently.
• Min. Degree in Science
• Has prior pharma background will be an advantage

If interested, please email your resume to [email protected]
➖
Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)

Our client is a global MNC, one of the most established pioneers in the Chemical industry. Due to business needs, they are now recruiting a Quality Assurance Engineer to be part of their QA/QC Team for ongoing transformation projects. They are located in the West - easily accessible.

Duties of Quality Assurance Engineer:

• Assisting in the research and development of Cement-based mortar formulations, including assessing alternative raw materials.
• Conducting tests on raw materials and finished products to ensure quality compliance.
• Validating product performance against industry standards and internal evaluation criteria.
• Ensuring products meet local regulatory standards.
• Providing manufacturing support, troubleshooting, and process improvement.
• Offering technical service, product trials, and training.
• Maintaining lab safety standards and workplace security.
• Any other adhoc duties as assigned

Requirements:

• Entry level are welcome to apply. Training provided.
• Experience with Dry Mixes is an added advantage

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified

• Email Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2199158
• EA Personnel Name: Soo Wei De

• Company: Manufacturing Company
• Location: Tuas West Road
• Position: QC Engineer (Job ID: 18812)

Job Description:

• Reports directly to the section manager and HOD
• Ensure that all supervisor(s) and technician(s) complete their testing and allocated work in a timely manner
• Conducts all laboratory tests, measurement and analysis when necessary and perform checks to ensure method accuracy for the measurement and analysis
• Ensure that GR&R is performed for the instruments and records are maintained
• Perform troubleshooting of instruments and facilities when there is any breakdown and ensure all maintenance and calibration is performed as per scheduled
• Perform validation and commissioning of new instruments and methods and maintain records of validation and commissioning
• Assist in technical evaluations in accordance to direction given after discussion
• Participate in customer complaints investigation (for analysis related complaint)
• Troubleshoots quality issues (within department - both sections)
• Maintains and updates the inventory record of all instruments/facilities parts (liaise with vendor for quotation) and ensures proper records and inventory level is maintained
• Monitor (and prepares reports) on QC instruments/facilities and EHS performance through statistical reports and initiate continuous improvement projects (including operation related)
• Participate in audits (internal and external)
• Assist the senior engineer and QC section manager in the design of laboratory facilities / laboratory expansion if any
• Ensures area housekeeping are done at all work areas
• Promotes and participate in QEHS activities and ensures that all procedures are strictly adhered by the supervisors and technicians in all aspects of the activities
• Understands Risk Management and ensures that the risks identified and the control measures are communicated to the supervisors and technicians
• Actively participates in all quality / environmental, health and safety programs conducted by the company
• Performs any other tasks as instructed by the senior engineer, QC section manager and HOD

Job Requirements:

• Min. Diploma in Chemistry/Chemical Engineering or any other science discipline
• Preferably with at least 3 years of relevant working experiences (Entry level candidates may also be considered)
• Good working knowledge of quality control standards and familiar with analytical instruments like ICP-MS, AAS, IC, TOC, etc
• Ability to communicate clearly in both writing and verbally and good interpersonal and presentation skills
• Strong understanding of ISO9001, ISO14001 and ISO45001 standards will be an advantage
• Proficient in Microsoft Office Tools

Interested applicants please apply directly to the role for further shortlisting.

We regret that only shortlisted candidates will be notified. Other applications will be updated to our database for future job opportunities.

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Effective from 1 October 2020 under the new Employment Agencies (EAs) Licence Conditions,

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Jeffrey Koh Kok Ann

EA Registration No: R1770345

Pasona Singapore Pte Ltd

1 FINLAYSON GREEN ＃09-02 SINGAPORE 049246

EA License No:90C4069

Responsibilities

• Hands on build and lead the team to create detailed, comprehensive and self write well-structured test plans and test cases from scratch
• Estimate, prioritize, plan and coordinate testing activities
• Proactively identify, record, document thoroughly and track all bugs
• Design and develop the team’s Automation Testing capability using internal Automation framework and system
• Design and develop thorough Regression Testing capability
• Develop from scratch and apply testing processes for new and existing products
• Liaise with internal teams (e.g. Engineers, Developers and Product Managers) to identify system requirements
• Manage the release process with Automation tools
• Track Quality Assurance metrics, i.e. defect densities and open defect counts

Requirements

• At least 7 years experience with strong hands-on capability, with at least 1 year of people management skill, preferably in the Payment/Pay/Wallet background
• Strong knowledge of Software QA Automation methodologies, Backend Testing, Auto frameworks and design processes
• Strong hands-on with CICD (Release process Agile knowledge)
• Must Have: Hands on solid coding / writing script capability in either Java/Python/Javascript
• Experience in writing clear, concise and comprehensive test plans and test cases
• Hands-on experience with both white box and black box testing
• Solid knowledge of SQL and scripting
• Experience working in an Agile/Scrum development process

Working here

• Work alongside diverse, world-class talent in an environment where learning and growth opportunities are endless

• Tackle fast-paced, challenging and unique projects

• Work in a truly global organization, with international teams and a flat organizational structure

• Competitive salary and benefits

• Flexible working hours, remote-first, and casual work attire

Our client is from Oil and Gas industry. They are looking for a C & I Engineer to assist their team for the next phase of their business. They are located in West.

Duties:

• Responsible for Yokogawa DCIS, SIS, and FGS support to ensure safe operations.
• Installation, troubleshooting, and maintenance of automation systems.
• Manage vendor contracts and provide technical training.
• Develop and maintain maintenance procedures and documentation.
• Execute projects related to automation and plan for system lifecycle.
• Lead Cyber Security compliance and conduct risk assessments.
• Offer expertise in OT cyber-security projects.

Requirements:

• Min Degree in Computer, Electrical Engineering or any relevant field.
• Min 4 years of working experience in Oil and Gas and utilities or any relevant industry.
• Experience in ISO27001 and IEC61508 will be anadvantange.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email Address: [email protected]

Recruitpedia Pte. Ltd.

EA License No: 19C9682

EA Reg. No. R23115873 (New Jirn Tone)

• Monday - Friday: 8.30AM- 6PM
• Working Location: Pioneer

Our client is a well-established manufacturer of hardware.

Responsibilities:

• Performing incoming & outgoing inspection of goods
• Ensuring inspection and test equipment are in good conditions and calibrated
• Performing calibration and maintenance for in-house measuring equipment periodically
• Documentation and verification of all inspections of goods
• To participate in Company’s continuous initiatives and training
• Other tasks as assigned by superior

Requirement:

• Min GCE ‘N’/ ‘O’ Level/ ITE Cert/ Diploma in related field
• At least 1 year of QA experience
• Basic computer skill(s): Microsoft Office
• Ability to work independently as it is a fast-paced working environment

HOW TO APPLY:

Interested applicants, please click on “Apply Now” or email to submit your resume.

We regret only shortlisted candidates will be notified.

Stafflink Services Pte Ltd

EA Licence No.: 04C4294

EA Personnel: Chua Xue Min (Joesefyn)

EA Personnel Reg. No.: R23113090

Our client, a startup in cryptocurrency derivatives trading platform in Singapore, is currently seeking for a Senior QA Engineer to join their team:

Responsibilities

• Experienced with QA lifecycle, from writing test plan, thinking through test case design, performing test execution (new feature and regression) to defect management and retrospect. Familiarity with the end-to-end software development life cycle is helpful when collaborating with other teams.
• Perform and drive Manual testing, Automation Testing and Performance Testing.
• Fully document any bugs/anomalies identified in testing with instructions how to recreate them.
• Accurately record and maintain test results, and its progress to resolution.
• Collaborate with Client Services team to help perform root cause analysis of issues found in the production environment.
• Identify and propose areas of improvement throughout the software development process.
• React quickly to changes in priorities or circumstances to meet the needs of the business.
• Continuous improvement of the testing process, testing quality and efficiency.
• Maintain good documentation and change controls.

Knowledge & Experience requirements

• Bachelor's degree or above in engineering, computer science or other related fields.
• At least 3 years of working experience in software testing development.
• A self-learner proficient in testing procedures and test case design methods who takes the initiative to do further technical research.
• Experience with automated testing frameworks (i.e., Selenium, Appium, Pytest).
• Working knowledge of API testing. Strong understanding of and experience in HTTP, WebSocket, JSON.
• Familiar with database and SQL.
• Familiarity with Performance Testing tools such as JMeter, Charles, Fiddler, Postman.
• Experience with a crypto exchange, or passionate about crypto.
• A proactive approach to problem-solving with strong analytical and research skills.
• Strong logical thinking ability, negotiation skills, and conflict management capability.
• Good at teamwork, result-oriented, and resilient.

Responsibilities:

• Responsible for working with the cross functional teams to improve the process / product quality and achieve the company and department KPIs
• Attending to customers on factory audit, quality issues and returns
• Responsible for resolving quality issues related to incoming, in-process, outgoing and customer complaints
• Providing support for New Product launch and raw material approval
• Overseeing the quality of new products from sample build to mass production by building a robust process
• Monitoring Supplier performance and liaising with suppliers to resolve quality issues and handing of Non-Conforming Material Report
• Conducting internal and external audits.
• Responsible for environmental compliance conformity of raw materials.

Requirements:

• Diploma with at least 3 years of experience in quality management / manufacturing environment/ Degree in the field of Mechanical/ Electrical & Electronics Engineering, Quality Certification or equivalent.
• Possess good knowledge of IATF16949, ISO9001, ISO13485 QMS, with auditing experience preferred.
• Experience in contract manufacturing of wire harness assembly, PCBA and Electro-mechanical assembly, handling of new products from new launch to mass production, on the Quality control & handing of customer complaint & returns.
• Experience on raw material compliance conformity (Eg.RoHS, Reach, Conflict of Mineral, Pro65) is preferred
• Good problem-solving & communication skills, resourceful and independent.
• Experienced in generating Quality procedures & knowledge of ESG Sustainability is an added advantage.

Responsibilities

• Responsible for leading root cause analysis & corrective action in nonconformance part investigation
• Responsible for establishing quality inspection plans, COC, procedures/ work instructionsHandle customer/supplier/ internal CARs
• Responsible for planning, coordinating & performing internal audits
• Responsible for performing gap analysis on standards revision and revise procedure/ work instructions
• Responsible for attending to customer/ supplier/ internal /certification audits & technical queries.

Requirements

• Min Diploma in Mechanical Engineering or equivalent
• Min 3 years of working experience in Oil & Gas/ Metal Machining Industry
• Experience in using measuring instruments such as caliper, bore gage, micrometer etc

Please kindly email your resume in Ms Word to [email protected]

We regret to inform that only shortlisted candidates would be notified.

Registration Number: R1328870

EA License No. 22C1026

Responsibilities

• Responsible for ensuring that corrective actions are in place and implemented for all non-conformances detected during audits
• Responsible for liaising with production side on the investigation of root cause of non-conformance and procedural failures
• Responsible for reviewing and approving required specifications and revisions in documentation prior releasing for production or customer
• Responsible for conducting process audit and internal quality scheduled/unscheduled audit
• Responsible for ensuring work is carried out in accordance with documented procedures

Requirements

• Min Diploma in Mechanical Engineering, Manufacturing or other relevant discipline
• Min 3 years of working experience in CNC/ Precision/ Machining Industry

Please kindly email your resume in Ms Word to [email protected]

We regret to inform that only shortlisted candidates would be notified.

Registration Number: R1328870

EA License No. 22C1026

Job Description:

• Liaison with customer reps on documentation procedures
• Update and review QMS documentation
• Conduct external and internal audits
• Analyze and follow up on audit findings
• Implementing Quality improvement programs or campaigns
• Conduct training on Quality and Safety
• Carry out investigation into incidents, accidents and customer complaints
• Carry out surveillance on work compliance, safety, good housekeeping and proper documentation

Job Requirements:

• Professional Certificate/NiTEC, Diploma
• Conversant with Airworthiness requirements and / or Quality Management System (AS9100)
• Internal auditor trained (ISO9001/AS9100)
• Knowledge of Microsoft Office applications.
• Excellent verbal and written communication skills.
• Able to work independently and in a team environment 1 to 2 years' experience in aviation
• Possess valid class 3 driving license is an advantage

Responsibilities

• Responsible for leading root cause analysis & corrective action in nonconformance part investigation
• Responsible for establishing quality inspection plans, COC, procedures/ work instructionsHandle customer/supplier/ internal CARs
• Responsible for planning, coordinating & performing internal audits
• Responsible for performing gap analysis on standards revision and revise procedure/ work instructions
• Responsible for attending to customer/ supplier/ internal /certification audits & technical queries.

Requirements

• Min 3 years of working experience in Oil & Gas/ Metal Machining Industry
• Experience in using measuring instruments such as caliper, bore gage, micrometer etc

Please kindly email your resume in Ms Word to [email protected]

We regret to inform that only shortlisted candidates would be notified.

Registration Number: R1328870

EA License No. 22C1026

Work Location : 6 Tampines Industrial Avenue 5 Singapore 528760
Work Day : Monday to Friday (8.30am to 5.30pm)

Responsibilities:

· To work with all internal departments & suppliers to create a friendly & ensure quality awareness environment so as to achieve zero defect products

· To lead & work with MRB team on the OSV activities so as to meet supplier's requests before any RMA / RTV process

· To understand customer manufacturing quality requirements & align with the business agreement so as to work effectively with suppliers on the line rejection

· Work closely with suppliers to expedite on-the-line defective returns, and follow-up on the disposition & FA report so as to work back with the internal relevant departments. Eg : SCM, Quality, Process and etc.

· Maintain zero defective quality on hand & aging period

· Support parts localization and work closely with factory RD & engineering team

· Compliance with RBA

Requirements:-

· Degree / Diploma in quality/engineering

· Ability to work with the customer, HQ / factory, Peers / Subordinate, and Superiors

· SAP knowledge

· Able to multi-task & work under pressure

· Able to handle customer complaints and work well with internal & external departments to resolve the quality issues

· Able to provide constructive solutions/advice to the team

· Participate in con-call outside office hours if required

Our client is from Oil and Gas industry. They are looking for a C & I Engineer to assist their team for the next phase of their business. They are located in West.

Duties:

• Responsible for Yokogawa DCIS, SIS, and FGS support to ensure safe operations.
• Installation, troubleshooting, and maintenance of automation systems.
• Manage vendor contracts and provide technical training.
• Develop and maintain maintenance procedures and documentation.
• Execute projects related to automation and plan for system lifecycle.
• Lead Cyber Security compliance and conduct risk assessments.
• Offer expertise in OT cyber-security projects.

Requirements:

• Min Degree in Computer, Electrical Engineering or any relevant field.
• Min 4 years of working experience in Oil and Gas and utilities or any relevant industry.
• Experience in ISO27001 and IEC61508 will be anadvantange.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email Address: [email protected]

Recruitpedia Pte. Ltd.

EA License No: 19C9682

EA Reg. No. R23115873 (New Jirn Tone)

Work Location: Tampines
Work Day: Monday to Friday (8.30am to 5.30pm)

Job Responsibilities:

• Maintain the Quality Assurance documents in the system

• To support various QA functions

• To coordinate and schedule all documentation control and audits

• To support internal audits to ensure compliance with regulations or standards such as ISO guidelines

• Reviewing data to identify and resolve risks to the organization’s quality standards

• Oversee documentation flow and record retention

• To support and prepare reports

• Any other ad-hoc duties assigned by superior

Requirements:

• Min “O” Level

• Minimum 1 year of relevant experiences

• Hands-on experience and knowledge in quality management system

• Proficient with Microsoft Word & Excel

• Customer Service Skills, Communication & Interpersonal Skills

• Team player, meticulous, customer-focused, dedicated

• Good written & spoken communication skills

Compliance with RBA standards

Compensation & Benefits

• Annual Increment
• Performance Incentive Bonus
• Career Progression

For quick reply, please contact me at +65 85878287

Registration Number: R21100938

EA Licence No: 22C1301 (Unisearch Services Pte Ltd)

• Overseeing the operation and whole function of QAQC department
• Establish, review and continuous improvement for Food Safety Management System (SFA Regulations / FSSC 22000 / HALAL / Customers’ requirement) and documentation.
• To lead the QAQC team towards managing, maintaining and food safety management system.
• Review and improve working procedure/criteria for manfacturing processes.
• Overseeing in export country registration, review of importing countries requirement and liaising with regulatory agencies.
• Assisting in laboratory set-up / Overview external lab testing Parameter
• Study the export /import, rule and regulation of the country
• Main point of contact for Government regulatory agencies and certification bodies.
• Any ad-hoc tasks assigned by superior

AWS+VB

Location: West

QA Operation - Product and Processes

• Be responsible for daily operations of the online QC support of UM Plant.
• Manage QC lab tech scheduling and plan work force utilization to ensure efficient use of resources.
• Ensure that products are effectively inspected/tested, and that product/process quality data conformed with specifications.
• Ensure continuous compliance to Good Manufacturing Procedures.
• Monitor and analyze process / product outputs, identify systemic problem / opportunity areas, provide data to the divisional team(s), and work with team members to drive process improvement project towards zero-defect quality performance.
• Lead to review effectiveness of corrective & preventive actions (CAPA) system.

Lab Operation

• Supervise QC laboratory operations.
• Coordinate with other departments and conduct investigations as an area expert for appropriate discrepancies.
• Assist in developing departmental strategic staffing plans and justifications for headcount and capital equipment requests.
• Promotes laboratory safety working culture. Review opportunity to achieve zero incident.

Quality Systems

• Perform as SAP Superuser for Quality function.
• Manage QA System sustainability.
• Lead to attain food safety management system certification, ie. ISO22K.
• Lead to plan and organize regular audits to the production and quality operations for compliance as well as to co-ordinate and document corrective action programs
• Lead to review Change Management, Audit management and CAPA Management are effective.
• Miscellaneous Duties (Improvement)
• Manage other Quality related projects as and when required.
• Any other work-related duties as assigned.

For consideration, kindly submit your CV by clicking “APPLY NOW” or text +65 8124 8100 for confidential discussion.

*Only shortlisted candidates would be notified**

MTC Consulting Pte Ltd | 15C7752

EA. Registration No.: R22106909 | Fiona Jayne Yong Yee Wen

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility in one of 6 areas: Quality Systems, QA Engineering, External QA, QA Excellence (Transformation and Technical Compliance), Quality Operations or Audit Management.

Key responsibilities:

• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.

• Display a good level of problem-solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience.

• Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections.

• Take on role of QA Specialist in Quality Operations.

• In depth awareness of entire process, identifying operational factors which influence the process.

• Review and approve change controls.

• Review and approve Master Batch Records (MBR), SOPs, protocols, reports or records.

• Support changeover activities.

• Support Annual Product Quality Review activities.

• Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken.

• Demonstrate ability to lead a small project and manage the deliverables effectively.

• Develop good working relationships with internal & external customers.

• Able to participate actively or lead in investigations, change controls, CAPA plans and closure of discrepancy reports.

• Develop skills as an internal GxP auditor, as required.

• Provide support in regulatory inspections and customer audits as required.

• Plan for future activities and coordinate with other departments to complete this.

• Develop skills to be Qualified Trainer in area of expertise.

• Any other tasks as and when assigned by supervisor.

Key requirements:

• Bachelor's degree with exposure in the Biopharmaceutical industry.

• Relevant experience from the Biopharma or any related environment.

• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.

• Knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.

• Meticulous and Systematic.

• Team player, with strong focus on safety, quality and timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

We provide company transport, both ways, at multiple pick up points.

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 team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

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 commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Create, review and approve Good Manufacturing Practices {also cGMP} validation documentation.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.

Qualifications

Must-Have

• Bachelor's Degree
• Experience in Quality administered systems
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills

Nice-to-Have

• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Key Responsibilities:

· QMS Implementation/ Maintenance and Regulatory Compliance

- Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with relevant standards and regulations.

- Ensure adherence to best practices, streamline processes, and drive innovation in the certification procedures.

- Stay up-to-date with national and international regulatory requirements related to medical device certification and be the key contact for regional colleagues.

- Interpret and communicate regulatory changes to internal stakeholders, ensuring ongoing compliance.

- Working with competent authorities (HSA)

· Regional Synergies Coordination

- Collaborate with regional teams to identify opportunities for synergies and standardization in certification processes.

- Foster communication and collaboration across regions to enhance efficiency and consistency in service delivery.

· Internal Audits

- Plan, support, and oversee internal audits to assess the effectiveness of the QMS.

- Identify areas for improvement, implement corrective actions, and monitor their effectiveness.

· Training Coordination

- Develop and deliver training programs on QMS, regulatory requirements, and certification processes.

- Coordinate regional training sessions to ensure a well-informed and skilled workforce.

Key Requirements:

· Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Engineering).

· Proven experience in implementing and managing Quality Management Systems, preferably in the medical device industry.

· In-depth knowledge of relevant regulations and standards (e.g. ISO 17021 ISO 13485)

· Strong project management and coordination skills.

· Excellent communication and interpersonal skills to work effectively across regional teams.

· Experience in conducting internal audits and driving continuous improvement initiatives.

· Ability to adapt to changes in regulatory landscapes and proactively integrate them into existing processes.

· Travelling in the region (10%)

• 7+ years of professional experience in QA / Testing and agile methodology
• Good team player, fast learner and good analytical skills
• Skilled in both Manual and Automation testing
• Understand requirements both functional and non functional and come up with test strategy, test plan and test cases.
• Able to coordinate with stake holders to communicate the test strategy. Facilitate signoff discussions with users and ensure they are able to understand and signoff.
• Self-organized and reliable person.
• Tooling experience in SQL Server/DB2/SQL, SOAP UI, XML, JIRA knowledge as it is used as a test management tool, affinity to automation
• Experience in Selenium, APPIUM, KATALON, TOSCA, API, WINDMILL is required

Responsibilities

• Responsible for developing of test scripts, issues tracking and test management
• Responsible for conducting qualification test of new product or revised component with issuing of test report and recommendations to the test findings
• Responsible for testing accordance to applicable product standards, guidelines, regulations and dormakaba Corporate Standard (DCS)
• Responsible for preparation of samples and coordinate with PQS EN or certification bodies for product certification
• Responsible for evaluating and analysis of competitors’ products – teardown analysis, VA/VE

Requirements

• Min Diploma in Engineering or relevant
• Min 2 years of working experience in production quality or test lab.

Please kindly email your resume in Ms Word to [email protected]

We regret to inform that only shortlisted candidates would be notified.

Registration Number: R1328870

EA License No. 22C1026

Responsibilities

• Responsible for creating detailed, comprehensive and well-structured inspection plans and collaborate with cross functions to improve tests and inspections
• Responsible for estimating, prioritizing, planning and coordinating customers’ escalations and feedback as well as investigating the causes of non-conformances and to implement solutions
• Responsible for initiating corrective actions for procedural, product or process deficiencies and handling of NCR/MRB/DMRB disposition, working with internal teams and Operations to look into Root Cause and Corrective actions (RCCA)

Requirements

• Min Diploma in Engineering or relevant
• Min 3 years of working experience in Manufacturing Industry in Quality

Please kindly email your resume in Ms Word to [email protected]

We regret to inform that only shortlisted candidates would be notified.

Registration Number: R1328870

EA License No. 22C1026