- Key ResponsibilitiesReview and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
- Ensure compliance with cGMP, SOPs, GDP and data-integrity requirements.
- Review manufacturing and packing activities for compliance with approved procedures.
- Handle deviations, incidents, OOS/OOT investigations and CAPA.
- Initiate and evaluate Change Controls and assess quality/regulatory impact.
- Participate in internal, customer and regulatory audits.
- Support regulatory inspections and ensure timely closure of observations.
- Review and approve SOPs, specifications, protocols and reports.
- Perform line clearance and in-process quality checks as applicable.
- Review environmental monitoring, cleaning validation and process validation documents, as applicable to the role.
- Support Annual Product Quality Review (APQR/PQR) activities.
- Ensure proper documentation, traceability and data integrity across quality records.
- Conduct and support GMP training for manufacturing and support functions.
- Identify quality risks and support Quality Risk Management (QRM) activities.
- Coordinate with Production, QC, Engineering, Warehouse, Regulatory Affairs and other departments.
- Drive continuous improvement and maintain a solid quality culture.
Strides states that its manufacturing sites operate under a unified global quality system with international GMP requirements, digital batch traceability, electronic batch records and LIMS.
- Required QualificationB.Pharm / M.Pharm
- B.Sc / M.Sc in Chemistry, Microbiology or related discipline may be considered depending on the position.
- Additional qualification in Pharmaceutical Quality Assurance / Regulatory Affairs is an advantage.