Quality Assurance Manager (OSD facility)

Role & responsibilities

• Lead IPQA activities for OSD Manufacturing and Packing operations, ensuring effective QA oversight across all manufacturing and packing stages.
• Ensure effective shop-floor QA management covering line clearance, in-process controls, in-process sampling, dispensing, manufacturing, compression, coating, encapsulation and packing activities, as applicable.
• Ensure products are manufactured and packed strictly as per approved procedures, specifications, BMR/BPR and Master Formula Records.
• Review and approve SOPs, BMR/BPR and other GMP documents through EDCS.
• Review and approve Master Formula Records (MFR).
• Review and approve Annual Product Quality Reviews (APQR) and Interim Product Quality Reviews (IPQR).
• Ensure implementation and compliance of approved SOPs, GMP and GDP requirements across Manufacturing and Packing areas.
• Ensure compliance with the Quality Management System and applicable regulatory requirements.
• Ensure effective execution and compliance of Process Validation, Cleaning Validation and Hold Time Studies.
• Review and approve Bills of Material (BOM) through ERP systems.
• Ensure stage-wise review and release of batches through LIMS and ERP systems.
• Ensure timely QA release of batches within defined timelines.
• Ensure online review of executed BMR/BPR, logbooks, records and electronic entries.
• Review and approve QMS documents through EQMS.
• Ensure daily online review of e-log entries and timely closure of discrepancies.
• Support and lead investigations related to deviations, incidents, OOS/OOT, market complaints and shop-floor quality events, as applicable.
• Review, implement and verify the effectiveness of CAPA arising from investigations, audits, deviations and complaints.
• Handle and oversee Change Control, Incident, Deviation and CAPA processes.
• Plan and conduct Self-Inspection/Internal Audits and ensure timely closure of observations.
• Coordinate and conduct quality risk assessments for manufacturing and packing processes as per the approved risk management framework.
• Ensure strict compliance with entry/exit procedures, gowning, color coding, personnel hygiene and other GMP requirements.
• Coordinate with Production, QC, Engineering, Warehouse, Regulatory and other functions for timely resolution of quality-related issues.
• Coordinate with cross-functional departments/sites for timely submission of required quality and regulatory documents to clients.
• Conduct and coordinate training on SOPs, GMP, GDP and other quality-related requirements.
• Ensure effective implementation of QA controls during manufacturing and packing operations, including prevention of mix-ups, cross-contamination, labeling/packing errors and documentation discrepancies.
• Monitor QA performance on the shop floor and identify opportunities for strengthening compliance and reducing recurring quality issues.
• Ensure work discipline and effective deployment of QA/IPQA personnel across Manufacturing and Packing areas.
• Mentor and guide the QA/IPQA team and ensure effective allocation and execution of departmental responsibilities.
• Support regulatory and customer audits and ensure timely and effective response to observations.
• Drive continuous improvement in IPQA systems, shop-floor compliance and quality culture within the OSD facility.

Preferred candidate profile