Quality Assurance Specialist

I. PRIMARY FUNCTION AND BASIC PURPOSE

Responsible for the implementation of in-process product and packaging materials monitoring in accordance with sampling plan and procedures to ensure that all products conform to the specified requirements of local and international regulatory agencies and clients.

II. RESPONSIBILITY AND ACCOUNTABILITY

A. JOB EXPECTATION

1. Correct, accurate and timely review and preparation of QA related documents such as GMP Certificates, Incoming Inspection reports (bulk and packaging materials), product discrepancy reports and delivery reports from warehouse.
2. Conducts routine in-line inspection to verify compliance of each process line against the created master packaging order, Pharmaceutical Inspection Co-operation Scheme or PIC/s and Good Manufacturing Practices. This also includes checking the environmental conditions of each line of production as well as the warehouse.
3. Suggest, recommend and provides action plans to aid unforeseen events that may directly affect the requirements set by the clients as stated in the Quality Technical Agreements and local or international standards.
4. Timely and accurately conduct inventory of retention samples, production rejects, and principal samples on a quarterly basis. This also includes encoding of sample details for proper documentation record keeping.
5. Ensures that all documents are always maintained in accordance with Good Documentation Practices. All hard copies of documents are kept up to date, as well as soft copies of records are updated.
6. Participates in all types of audits including internal, customer and/or any external audits.

B. RESPONSIBILITIES

1. Supervises and oversees the performance of QC Inspectors and cGMP Inspectors, including continuous monitoring of their assigned tasks and verification of inspection activities to ensure accuracy, completeness, and compliance with internal procedures and cGMP requirements. Reviews and verifies inspection records and reports, ensures proper documentation, and provides direction, coaching, and corrective actions when required.
2. Key personnel responsible for preparing the discrepancy reports, GMP report and inventory of retention samples, product rejects, and principal samples. He/ She was also responsible for ensuring product sample database, sample retention database, and is kept up to date.
3. Ensures that production activities are aligned with the client requirements. Accurately identify defects in the product and coordinate with clients regarding disposition. He/She will also be responsible for discussing the client disposition to all related departments. He/She will also monitor the effectiveness of the disposition given.
4. Supports QA Supervisor and/or QA Manager in ensuring that the batch records are complete, and correct prior release. Conducts actual finished product inspection prior dispatch to ensure that all products release adheres to the requirements stipulated in the Master Packaging Order as well as compliance with PIC/S, and GMP.
5. Ensures that all close batch records per client is well kept including Master Packaging Order. He / She is responsible for correct filing of documents for easy tracking during the audit.
6. Participates in any customer and regulatory audits and may act as auditor during supplier and / or internal audits.
7. Coordinates with the Production team for the result of any quality-related concerns raised including proper documentation.
8. Responsible for reporting any significant changes or deviations found in the line to QA Supervisor and/or QA Manager.

III. PERFORMANCE STANDARDS

1. Timely and correct bulk finished goods and packaging materials release.
2. Timely release of inspection reports.
3. Conformance to Good Manufacturing Practices and compliance to Safety, and other regulatory requirements.

IV. KEY ORGANIZATIONAL RELATIONSHIP

1. Reports directly to QA Supervisor; QA Manager if necessary.
2. Will take post for all activities of QA Supervisor in his/her absence and vice versa

3. Coordinates with:

• Production Department
• Warehouse Department
• PPIC Department
• Accounting and Purchasing Department
• Quality Assurance Department
• Regulatory Affairs Department

V. QUALIFICATION REQUIREMENTS

1. College level or graduate in any 4 years course related to pharmaceutical industry
2. Preferably experienced in pharmaceutical industry and with relevant knowledge to Quality Management System, PICS and cGMP
3. Diligent and keen observant
4. Good in oral and written communication
5. Computer Literate

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