Manager - Quality Assurance

Quality Assurance (QA):

- Establish, implement, and maintain Quality Management Systems (QMS) in compliance with cGMP, ICH, and global regulatory standards.

- Review and approve SOPs, specifications, validation protocols, change controls, deviations, CAPA, and batch manufacturing records.

- Ensure GMP compliance across production, packaging, warehousing, and quality functions.

- Lead investigations for deviations, OOS, OOT, and customer complaints.

- Oversee qualification and validation activities (equipment, process, cleaning, analytical methods).

- Conduct internal audits and prepare the facility for regulatory inspections (USFDA, EMA, MHRA, PMDA, WHO, etc.).

- Manage vendor qualification, supplier audits, and material approvals.

Quality Control (QC):

- Oversee QC laboratory operations including chemical, instrumental, and microbiological testing.

- Review and approve analytical reports, Certificates of Analysis (COA), stability studies, and validation documents.

- Ensure proper calibration and qualification of analytical instruments (HPLC, GC, FTIR, UV, etc.).

- Manage OOS/OOT investigations and ensure timely closure.

- Implement GLP and ensure data integrity compliance.

Leadership & Management:

- Lead, mentor, and train QA and QC teams to build a strong quality culture.

- Coordinate with cross-functional teams to ensure product quality and regulatory compliance.

- Ensure timely release of raw materials, intermediates, and finished API products.

- Drive continuous improvement initiatives, including QMS enhancement and process optimization.