Executive - Quality Assurance (IPC)

Position Summary:

The Executive – QA (In-Process Control) is responsible for ensuring compliance with Good Manufacturing Practices (GMP) through effective in-process monitoring, line clearance, and quality oversight in sterile/parenteral manufacturing areas. The role involves real-time floor quality assurance, supervision of IPC activities, investigation of non-conformances, and coordination with cross-functional teams to maintain product quality and regulatory compliance. The incumbent will support validation, development, and scale-up batches while driving continuous improvement initiatives.

Job Responsibilities:

• Perform in-process control (IPC) activities, including line clearance and in-process checks in Sterile / parenteral manufacturing areas.
• Ensure continuous monitoring and inspection to maintain compliance with GMP, WHO, ICH, and internal quality standards.
• Supervise and guide IPC teams in Biotech and Secondary Packaging areas.
• Oversee QA compliance activities across shifts (Day/Night).
• Conduct shop floor investigations for deviations, non-conformances, and quality incidents; ensure timely closure with appropriate CAPA.
• Verify and approve batch rejections, returns, and disposition of rejected semi-finished goods (SFG) and packaging materials as per the approved Level of Authority.
• Participate in validation, development, and scale-up batches, ensuring adherence to approved protocols.
• Prepare, review, and revise Standard Operating Procedures (SOPs) and ensure effective implementation through training.
• Ensure timely reporting and escalation of product, process, and procedural issues, and monitor them through resolution.
• Collaborate with Production, Engineering, and Supply Chain teams to improve OEE (Overall Equipment Effectiveness).
• Maintain accurate documentation and ensure data integrity in line with GMP and regulatory requirements.

Required Qualification, Knowledge and Skills:

• Holds a professional degree of Pharmacy (Pharm D) or Master's degree in Chemistry / Applied chemistry
• 1 to 3 years of relevant experience in Quality Assurance – In-Process Control (IPC), preferably in sterile, parenteral, or biotech manufacturing facilities.
• Experience in GMP-regulated pharmaceutical manufacturing environments is preferred.
• Strong knowledge of Good Manufacturing Practices (GMP) with basic understanding of WHO, ICH, and ISO guidelines.
• Hands-on experience in in-process checks, line clearance, and shop floor QA activities.
• Ability to handle deviation investigations, non-conformance reporting, and CAPA follow-up.
• Good documentation practices (GDP) and data integrity awareness.
• Strong analytical and data compilation skills.
• Effective communication and report writing skills.
• Problem-solving mindset with attention to detail.