Qc Chemist

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 will be responsible for managing the training of Quality Control laboratory personnel that includes but not limited to:

- Coordinate and develop training materials and conduct instructor led / On job trainings.
- Induction of new hire and for assignment of new roles.
- Ensure effectiveness of training and knowledge retention of trainees.
- Capturing, retaining and archival of training related records.
- Ensure the audit readiness and presenting during audits.

The incumbent will be responsible for the management of stability program and associated activities in the Quality Control laboratory that includes but not limited to:

- Work with the different functions (QC, QA, regulatory and Production) to ensure stability batches are nominated and tested within the agreed timeline as per site procedures.
- Providing support on any stability request.
- Understand GMP principles in the QC laboratory and comply with Data Integrity requirements (ALCOA+)

How You Will Achieve It

Training
- Conduct orientation training for the new colleagues and mentor them till they are competent to perform task independently.
- Conduct instructor lead training and refresher training
- Identify training needs and conduct/organize training to close the training gaps. Assist QC supervisors/Managers to administer Job Training Curricula of the QC analysts and chemists
- Assess training effectiveness and knowledge retention of the relevant trainings.
- Administer proper documentation for all training related forms and records - Learning Records, assessments, evaluations, Course Information Forms, Learning Requisitions.
- Proficient in PLA (Pfizer Learning Academy) and able to manage the training requirements of the QC Team, which includes coordinating all training activities and facilitating group training for the team.
- Monitor training completion rate and provide metrics to the QC Tier 2.
- Coordinate with other functions for internal and external training arrangement for the QC team.
- Participate in safety and quality incident investigation to identify opportunities for continuous improvement to training related gaps and human performance factors
- Plan and Schedule training for shift colleagues including their off/rest days.
- Liaising with Technical Learning and capability (TLC) to improve the training effectiveness for QC team
- Liaise with external training providers to source and organize relevant training for the QC team
- Management of regulatory inspection to present QC training system.

Stability
- Manage stability testing with different functions to ensure stability studies (Annual, validation and adhoc) are identified and promptly initiated in QC laboratory.
- Track and monitor stability samples within the QC laboratory are promptly tested and completed within the agreed timeline as per site procedures.
- Ensure all stability testing records are reviewed and trending of stability data to confirm adverse trends, stability OOS Or questionable results.
- Prepares annual stability reports and ad hoc stability reports for Annual Product Review and regulatory submission.
- Act as the Subject Matter Experts for QC for all stability related topics and manage regulatory inspection for stability related topics.
- Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
- Conduct investigations relating to Stability studies.
- Ensure stability testing records and all documentations related to stability are conducted in accordance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements and that they are filed in accordance to existing policies.

**Qualifications**:

- For a Diploma: A minimum of 5 years QC experience in the pharmaceutical or related industry.
- For a Degree: A minimum of 3 years QC experience in the pharmaceutical industry.

Nice-to-Have
- Experience in traditional and modern training methods (mentoring, coaching, on-the-job, in classroom training, e-learning, workshops, simulations etc.).
- Experience in developing high-quality training materials (including those with pictures, animations, videos and simulations) that are impactful and emphasize pharmaceutical industry standards/regulations.

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.

Quality Assurance and Control

LI-PFE