About this role
- Perform IPQA activities on the manufacturing and packaging shop floor.
- Conduct and document line clearance before starting manufacturing and packaging activities.
- Perform in-process checks during dispensing, sifting, granulation, blending, compression, coating and packing operations.
- Verify critical process parameters and ensure compliance with approved BMR/BPR and SOPs . Review manufacturing and packaging records for completeness, accuracy and compliance.
- Monitor compliance with GMP, GDP, SOPs and data integrity requirements . Verify equipment status, cleanliness, calibration status and area readiness before operation.
- Monitor environmental and personnel practices on the shop floor.
- Identify and report deviations, incidents, non-conformances and GMP observations . Participate in investigation of deviations, OOS/OOT, incidents and customer/regulatory observations as applicable.
- Support preparation and implementation of CAPA . Review and verify reconciliation of raw materials, packing materials and finished products . Perform sampling and inspection activities as per approved procedures.
- Ensure proper control and documentation of yield, reconciliation and process parameters . Verify dispensing and material transfer activities as per approved procedures.
- Support change control, risk assessment and process validation activities.
- Ensure proper handling and documentation of rejected, returned and rejected materials/products.
- Monitor housekeeping and GMP compliance in production and packaging areas.
- Participate in self-inspections, internal audits, customer audits and regulatory inspections . Coordinate with Production, QC, Warehouse, Engineering and other departments for quality-related issues.
- Ensure timely closure of QA-related observations and documentation.
Provide GMP and SOP-related training to production personnel as required.
Qualification B.Pharm / M.Pharm – Preferred B.Sc / M.Sc (Chemistry) may also be considered based on relevant experience.
Experience 2–6 years of relevant experience in IPQA/Production QA in a pharmaceutical formulation manufacturing plant.
Experience in OSD manufacturing will be preferred.
Technical Skills Good knowledge of cGMP, GLP, GDP and pharmaceutical QMS . Strong understanding of BMR/BPR and SOP documentation . Knowledge of OSD manufacturing processes: Dispensing Sifting Granulation Blending Compression Coating Capsule filling Primary/secondary packaging Knowledge of deviation, CAPA, change control and risk assessment . Understanding of ALCOA+ and data integrity . Knowledge of line clearance and in-process checks.
Basic knowledge of process validation and cleaning validation . Familiarity with SAP/QMS/DMS/LIMS is an advantage.
Key Competencies Strong attention to detail GMP compliance mindset Good documentation skills Analytical and problem-solving ability Effective communication and coordination Ability to work on the shop floor Ability to identify and escalate quality risks Good understanding of pharmaceutical manufacturing processes