Officer - Quality Assurance

Job Description:

Key Responsibilities

1. Quality System Management and Compliance:

• Implement, maintain, and monitor the company's Quality Management System (QMS) as it relates to API manufacturing.

• Ensure all processes, procedures, and documentation comply with cGMP, regulatory guidelines, and corporate policies.

• Conduct routine inspections and on-line process checks to ensure adherence to standard operating procedures (SOPs) and batch records.

• Participate in internal and external audits (e.g., by regulatory bodies, customers, and third-party auditors).

• Assist in the preparation and review of responses to audit findings and ensure the timely implementation of corrective actions.

2. Documentation and Record Keeping:

• Review and approve manufacturing and quality control documents, including Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), raw material and finished product specifications, and Certificates of Analysis (CoAs).

• Draft, review, and revise Standard Operating Procedures (SOPs), protocols, and other quality-related documents.

• Manage and control all quality-related documentation, ensuring proper version control, storage, and retrieval.

• Ensure accurate and complete documentation for all quality assurance activities, including deviations, change controls, and CAPAs.

3. Investigations and Quality Events:

• Initiate, investigate, and close deviations, incidents, and non-conformances in a timely and effective manner.

• Perform root cause analysis (RCA) for quality events and recommend appropriate Corrective and Preventive Actions (CAPA).

• Monitor the implementation and effectiveness of CAPAs to prevent recurrence.

• Assist in the investigation and resolution of market complaints and product recalls.

• Review Out of Specification (OOS) and Out of Trend (OOT) results, and coordinate with the Quality Control (QC) and Production departments to conduct thorough investigations.

4. Validation and Qualification:

• Participate in the review and approval of validation protocols and reports for equipment, processes, and cleaning.

• Ensure that all critical equipment and systems are qualified and maintained in a validated state.

• Review and approve documents related to the qualification of new and existing vendors and suppliers.

5. Training and Continuous Improvement:

• Provide training to manufacturing and other relevant personnel on GMP regulations and quality procedures.

• Foster a culture of quality awareness and continuous improvement within the organization.

• Identify opportunities for process and quality system improvements and participate in their implementation.