Quality Design Assurance

• 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 strong 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.