Executive & Senior Executive - Quality Assurance (IPQA)

Job Title: Executive/Sr. Executive Quality Assurance Key Responsibilities
1. Shop Floor Monitoring & Line Clearance

• Line Clearance: Verify the cleanliness, readiness, and status of areas, equipment, and materials before initiating dispensing, granulation, compression, coating, filling, or packaging batches.
• Real-Time Surveillance: Conduct routine plant rounds to monitor active manufacturing processes, ensuring operators strictly adhere to established SOPs and cGMP standards.

2. In-Process Testing & Sampling

• Perform IPC Checks: Execute or witness in-process quality tests
• Sampling Operations: Collect in-process, finished product, validation, and control samples according to defined sampling protocols.
• Environmental Monitoring: Assist in monitoring cleanroom parameters, including non-viable particle counts, viable monitoring, and compressed air/nitrogen gas checks where required.

3. Documentation & Batch Record Review

• BMR/BPR Review: Review Batch Manufacturing Records (BMR).
• Document Control: Control the issuance, reconciliation, and retrieval of manufacturing logs, labels, and container seals.

4. Deviation & Event Management

• Identify Non-Conformances: Halt operations or intervene immediately on the shop floor if process deviations, equipment malfunctions, or quality risks are detected.
• Investigation Support: Assist QMS and production teams in documenting deviations, performing root-cause analysis (RCA), and implementing effective Corrective and Preventive Actions (CAPA).

5. Audit Readiness & Compliance

• Audit Support: Maintain the shop floor in a continuous state of inspection readiness for internal, client, and regulatory audits (e.g., FDA, MHRA).

Contact - Praveen Kumar

Mail: [email removed]

Mobile: [phone removed]