QA Specialist

**Career Progression Program (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals**

We are pleased to announce the Career Progression Program (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals, a distinguished talent development initiative aimed at cultivating the next generation of skilled professionals for Singapore's biopharmaceutical manufacturing industry.

**Program Overview**:

- **Program Type**:Mid-Career Change
- **Duration**:15 months
- **Training Allowances**:CPF exempted

This comprehensive program is meticulously designed to provide participants with the requisite skills and experience to meet the anticipated hiring demand within the biopharmaceutical manufacturing sector.

**Use Your Power for Purpose**

The Tuas, Singapore active pharmaceutical ingredient (API) manufacturing site is a key strategic manufacturing part of the PGS Network. Many of the Pfizer’s important new innovative medicines are being transferred to the Site to support the overall growth and breakthrough strategy

Whether you are managing projects, or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives

**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 / Lead QA Specialist, the incumbent will be responsible for the following:

- Drive quality culture and promote GMP compliance behaviours to the site.
- Provide QA oversight to the site GMP operations to ensure products produced in compliance with the Pfizer Quality Standards (PQS) and ICH guidelines
- Collaborate with cross functional teams to improve quality systems.
- Understand regulatory expectations and support site inspection readiness.
- Work with supply chain and drug product sites to ensure timely delivery of quality products.
- Work with GCMC to file products and address regulatory queries in an accurate and timely manner.

**How You Will Achieve It**

**Responsibilities**:

- Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with Pfizer quality standards and regulatory registered specifications.
- Review QC lab worksheets for intermediates, APIs and cleaning samples.
- Disposition of the intermediates and active pharmaceutical ingredients (API), including re-evaluation.
- Review and approve cleaning records and procedures and ensure compliance with the Pfizer Quality Standards (PQS) and guidelines.
- Support production startup activities including new product introduction (NPI), changeover activities, equipment releases, module clearance etc.
- Tank farm monitoring and QA oversight of the solvent recovery processes.
- Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards (PQS).
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Act as label administrator and manage Category 1 manual labels according to stipulated procedure.
- Write deviations according to the site procedures. Ensure issues are escalated according to the Pfizer Quality Standards (PQS).
- Coordinate with cross-functional team to prepare Annual Product Record Review, discuss trends and atypical observations and recommend improvement actions.
- Support and facilitate product return process.
- Support internal audits to ensure the internal controls are effective.
- Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walkdowns to ensure site operation and facility maintained in inspection ready state.
- Support the maintenance of validated stated of GMP systems and processes.
- Support regulatory queries in a timely manner, eg regulatory COA issuance.
- QA oversight of site processes and systems e.g. pest control program, warehouse and engineering (calibration and preventive maintenance).
- Continuous improvement on quality processes and practices on site.
- Any other tasks as assigned by manager.

**Organizational Relationships**:
The incumbent will interact with all site departments for GMP related operations and activities i.e. Manufacturing Operations Process Teams, Quality Control, Warehouse and Tank Farm teams and Engineering teams. In the event of quality or regulatory related issues, this position will inter