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Senior Qc Chemist/ Qc Chemist

2 weeks ago

Singapore Pfizer Full time

Company Description

Entrusted by Pfizer Singapore, Cielo Talent supports Pfizer to recruit permanent employees for the expansion of Pfizer Tuas manufacturing site in Singapore.

**Why Pfizer**

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

**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.

**Job Description**:
The incumbent is a member of the Quality Control (QC) Laboratory team. Reporting to the QC Systems Manager, the incumbent will be responsible for QC systems related to Empower software and gLIMS. Key accountabilities includes:

- Set up laboratory data systems related to Empower and gLIMS that are integrated with corresponding processes (e.g. Lot / sample end-to-end flow from creation to lot release, laboratory data review processes)
- Operational activities for maintenance and updates / troubleshooting of Empower and gLIMs (e.g. user training, periodic reviews, investigations etc)
- Ensuring Empower and gLIMS set up and related processes comply with current Good Manufacturing Practices (cGMPs), Data Integrity (DI) requirements, site Standard Operating Procedures (SOPs) and Pfizer Quality Standards (PQS).
- Lead projects for improvement of QC laboratory data systems including DI initiatives.

**Responsibilities**:

- Provide operational support (e.g. methods / configuration setup, troubleshooting) for gLIMs and Empower to ensure batch release and lab testing activities is maintained inline with committed schedules.
- Timely completion of template built and specification updates to support changes and New Product Introduction (NPI).
- Write and review procedures governing QC systems (e.g. gLIMS, Empower) and related documentation (e.g. protocols and reports), ensuring adherence to site SOPs and PQS.
- Perform and support activities in the system life cycle of QC laboratory equipment (e.g. periodic reviews, electronic data archival, decommissioning) in accordance with site SOPs.
- Author training documentation and perform training (e.g. Structured On-The-Job Training or SOJTs) for fellow colleagues on SOPs pertaining to gLIMS, Empower or equipment operation, maintenance and administration (as applicable).
- Lead and conduct investigations for deviations affecting QC laboratory systems (e.g. data loss in Empower), identify root cause(s) and implement appropriate corrective action and preventive measures.
- Ensure all data management in Empower comply to site SOPs, DI and ALCOA requirements per PQS and that they are archived / retained in accordance to existing procedures.
- Lead projects for improvement of QC laboratory systems including Data Integrity initiatives and support the QC laboratory data management strategy.
- Uphold Pfizer's code of conduct and values.
- Collaborate with cross-functional teams to drive flawless execution.
- 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.
- Mentor junior members (including interns) within the QC Systems team.

**Qualifications**:
Job Related Requirements:

- Demonstrated leadership and customer service skills.
- Effective problem solving skills.
- Demonstrate ability to act decisively and independently to resolve issues.
- Strong verbal, written communication and presentation skills.
- Demonstrated ability to perform in a team and provide mentorship to team members.
- 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.
- Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories.
- Comprehensive knowledge of Labware LIMS, Empower and laboratory equipment.

Education And Experience
- Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology.
- For a Diploma: A minimum of 8 years QC experience in the pharmaceutical or related industry.
- For a Degree: A minimum of 4 years QC experience in the pharmaceutical or related industry.
- Comprehensive knowledge of LIMS labware, laboratory instrumentation, Empower software, GMP compliance andData Integrity requirements for Quality Control laboratories is a must.

Additional Information

All your information will be kept confidential according to EEO guidelin