Executive - Quality Assurance

• 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