Executive / Senior Executive - Injectable Manufacturing QMS

Role & responsibilities: -

Documentation & Compliance

• Investigate deviations: Write thorough, scientifically sound investigation reports for deviations occurring on the shop floor.
• Determine CAPA: Identify Root Causes using tools like Fishbone or 5 Whys and implement Corrective and Preventive Actions.
• Manage Change Controls: Initiate, review, and track change controls for equipment, processes, and documentation.
• Handle OOS/OOT: Assist in investigating Out of Specification (OOS) and Out of Trend (OOT) environmental monitoring results.
• Review BMR/BPR: Review Batch Manufacturing Records and Batch Packing Records for compliance before QA submission.

Shop Floor QMS Oversight

• Monitor compliance: Ensure the injectable manufacturing area strictly follows current Good Manufacturing Practices (cGMP).
• Track audit trails: Review electronic audit trails for manufacturing equipment and compounding systems.
• Audit preparation: Participate in facing regulatory audits (USFDA, MHRA, etc.) and managing internal audit responses.
• Logbook management: Maintain and review online logbooks, validation protocols, and area qualification documents.

Process & Sterile Integrity

• Media fill participation: Draft protocols and execute Media Fill (Process Simulation) validation programs.
• Risk assessments: Conduct Quality Risk Management (QRM) studies for sterile compounding and filling lines.
• SOP drafting: Write and revise Standard Operating Procedures (SOPs) for manufacturing operations.

Preferred candidate profile

• Required Experience: - 5 to 12 Years
• Required Qualification: - B. Pharm. / M.Pharm.