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Tuas, Singapore Pfizer Full timePosition Summary The incumbent is member of the Quality Control (QC) Laboratory team. Under the supervision of the QC Laboratory Supervisor, the incumbent will be responsible for performing all analytical testing and the review of the test results generated and provides technical support to the laboratory and other departments. In additional to testing and...
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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 Control (QC) AS&T team. Under the supervision of the QC Manager/Supervisor, the key responsibilities are:
- Perform method transfer, method validation, method verification to site SOPs and relevant protocols, adhering to ALCOA principles and Data Integrity (DI) requirements.
- Assist in troubleshooting laboratory technical problems and support laboratory investigations.
- Use IMEX "way of working" for day to day operations, problem solving, escalation and continuous improvement.
How You Will Achieve It
- Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements.
- Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
- Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed.
- Able to assess the impact to products based on compendial monograph changes/updates/introduction.
- Able to support regulatory submissions and queries for post transfer activity.
- Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
- Conduct Laboratory investigations and propose CAPA for the identified root cause.
- Train colleagues in hands on training of instruments and methods written
- Perform review and approval of test results.
- Able to write position paper, protocols, reports and test procedures.
- Ability to handle QTS actions and raise and complete change controls for changes with GMP impact.
- Involve in regular meeting with donating site and facilitate the smooth transfer of the methods.
- Conduct training for fellow QC colleagues on new methods in the laboratory.
- Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalation. Support development and implementation of solution.
- Perform cleaning method development and validation.
**Qualifications**:
- Diploma in Science with minimum of 5 years QC experience or Degree in Science with minimum of 3 years of experience in the pharmaceutical or related industry
- Experience working in Good Manufacturing Practices (GMP) environment.
- Demonstrated technical skills in method transfer, validation, verification and testing,.
- Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
- Excellent organizational skills and strong ability to multi-task across projects and activities.
- Strong written and verbal communication skills
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
LI-PFE
