Qa Specialist 18 Months Of Training Programme
Tuas, Singapore
Job Description
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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
The incumbent is a member of the Quality Assurance team. Under the supervision of the Senior QA Manager, the incumbent will be responsible for the following:
- Provide Quality Assurance oversight to site operations (primarily Production, Quality Control, Warehouse, Engineering) to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines.
- Work with supply chain and downstream / drug product sites to ensure timely delivery of quality products.
- Support regulatory team to file products and address regulatory queries in an accurate and timely manner.
- Understand regulatory expectations and support site inspection readiness.
- Drive quality culture and promote GMP compliant behaviours at the site.
- Drive improvement of quality systems in collaboration with cross functional teams.
- Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way.
- Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.
How You Will Achieve It
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Responsibilities: - Review and approve GMP documentation to ensure their compliance with PQS.
- Disposition intermediates and active pharmaceutical ingredients (API).
- Handle deviations, laboratory investigations, product complaints according to site procedures.
- Handle duties related to DPOC (Designated Point of Contact) and super user for assigned site platforms supporting quality systems (e.g. Trackwise, Vault QMS, SAP) as nominated.
- Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
- Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
- Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes.
- Qualify and manage vendors according to PQS and maintain accurate records of vendor status. Review and analyze the quality related issues from vendors and recommend improvement actions to mitigate compliance risks. Ensure vendors and materials are qualified as required to support production schedule.
- Conduct internal audits to ensure internal controls are effective. Conduct external audits to ensure adequate oversight to vendors and collaborate with vendor to reduce material quality issues.
- Manage logistics for internal and external GMP inspections, including site communications and training.
- Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintainedin inspection ready state and adhere to site procedures and PQS.
- Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner.
- Ensure gap analysis of site procedures against PQS is performed by relevant SMEs in a timely manner meeting requirements for rollout of new / updated PQS / Policy Memos.
- Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks.
- Support the maintenance of validated state of GMP systems and processes.
- 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.
- Collaborate with cross-functional teams to drive flawless execution.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).
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Job Related Requirements: - Demonstrate ability to act independently to resolve issues, with appropriate escalations (as required).
- Strong verbal, written communication and presentation skills.
- Demonstrated ability to perform in a team.
- Possess a can-do / pride to succeed attitude
- Embrace the use of digital technology to scale and speed up every form of interaction and action.
Qualifications
- Degree in Chemistry, Microbiology, Engineering or other Science related discipline.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Job Detail
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Job IdJD1292824
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationTuas, Singapore
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EducationNot mentioned