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

📌 Quality Assurance Manager (OSD facility) (Baddi)
🏢 Acme Generics
📍 Baddi