Executive / Senior Executive - Injectable Manufacturing QMS

Intas; Bavla; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Intas is seeking a QA/Compliance professional to oversee documentation and compliance for injectable manufacturing. The role focuses on deviations, CAPA, change controls, and OOS/OOT investigations within a cGMP environment.

You will review BMR/BPR, monitor audit trails, and prepare for regulatory audits. The position involves SOP drafting and logbook management in a sterile manufacturing setting in Gujarat, India.

Qualifications

• 5 to 12 years of experience in pharmaceutical QA/compliance is required.
• B. Pharm. or M. Pharm. qualification is mandatory.

Responsibilities

• Investigate deviations: write thorough, scientifically sound investigation reports for deviations on the shop floor.
• Determine CAPA: identify root causes using 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 and Out of Trend environmental monitoring results.
• Review BMR/BPR: review Batch Manufacturing Records and Batch Packing Records for compliance before QA submission.
• Monitor compliance: ensure the injectable manufacturing area follows cGMP.
• Track audit trails: review electronic audit trails for manufacturing equipment and compounding systems.
• Audit preparation: participate in facing regulatory audits (USFDA, MHRA) and manage internal audit responses.
• Logbook management: maintain and review online logbooks, validation protocols, and area qualification documents.
• Media fill participation: draft protocols and execute Media Fill validation programs.
• Risk assessments: conduct Quality Risk Management studies for sterile compounding and filling lines.
• SOP drafting: write and revise SOPs for manufacturing operations.

Skills

cGMP compliance

Quality systems

Education

B.Pharm. / M.Pharm.

Job description

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.