Officer/Sr. Officer- Quality Assurance (QA)

Ensure implementation and compliance of GMP/cGMP, SOPs and Quality Management Systems (QMS) throughout manufacturing operations.

Review and verify BMR, BPR, SOPs, specifications and other quality-related documents.

Perform and document line clearance, in-process checks and area inspections as per approved procedures.

Monitor production activities to ensure compliance with approved processes, procedures and quality standards.

Review and handle deviation, OOS/OOT, change control and CAPA processes in coordination with relevant departments.

Ensure proper documentation, data integrity and timely completion of QA records.

Coordinate with Production, QC, Engineering, Warehouse and other departments to resolve quality-related issues.

Participate in validation, qualification, internal audits, self-inspection and regulatory inspections.

Identify potential quality risks and support continuous improvement of quality systems.

Ensure proper implementation of Good Documentation Practices (GDP) and data integrity principles.

Prepare QA reports and maintain necessary records for regulatory and management review.

Perform any other duties and responsibilities assigned by the management.