Manager

Manager – Quality Assurance (OSD & Injectable) – IPQA, Packing & Manufacturing (Formulations)

Job Purpose

To ensure compliance with cGMP, regulatory requirements, and quality standards by overseeing In-Process Quality Assurance (IPQA) activities during manufacturing and packing of Oral Solid Dosage (OSD) and Injectable formulations. The role is responsible for maintaining product quality, ensuring process compliance, and supporting successful regulatory inspections and audits.

Major Responsibilities

• Lead and manage IPQA activities for OSD and Injectable manufacturing and packing operations.
• Ensure compliance with cGMP, SOPs, data integrity, and regulatory guidelines (USFDA, MHRA, EU GMP, WHO, etc.).
• Perform line clearance, in-process checks, and stage-wise quality verification during manufacturing and packaging.
• Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), logbooks, and other GMP documentation.
• Investigate deviations, OOS/OOT, market complaints, and quality incidents, and ensure timely CAPA implementation.
• Review and approve change controls, risk assessments, and quality-related documentation.
• Monitor environmental and process compliance, ensuring adherence to quality standards.
• Support process validation, cleaning validation, media fills (Injectables), and qualification activities.
• Participate in internal audits, self-inspections, customer audits, and regulatory inspections.
• Provide GMP and quality compliance training to production and QA personnel.
• Coordinate with Production, QC, Engineering, Warehouse, and Regulatory Affairs to ensure smooth manufacturing operations.
• Track quality metrics, identify improvement opportunities, and drive continuous quality improvement initiatives.
• Ensure readiness for regulatory inspections and maintain an audit-compliant manufacturing environment.
• Lead, mentor, and develop the IPQA team to achieve departmental quality objectives.

Key Skills

• In-Process Quality Assurance (IPQA)
• OSD & Injectable Manufacturing
• Packing Quality Assurance
• cGMP, GDP, Data Integrity
• Regulatory Compliance (USFDA, MHRA, EU GMP, WHO)
• Deviation, CAPA, Change Control
• Batch Record Review (BMR/BPR)
• Process & Cleaning Validation
• Internal & Regulatory Audits
• Team Leadership and Cross-functional Coordination

Qualification : B Pharma / M Pharma / MSc