Assistant Manager & Deputy Manager - Quality Assurance (IPQA)

Job Title: Assistant Manager In-Process Quality Assurance (IPQA)
Key Responsibilities
1. Team Leadership & Shop-Floor Governance

• Supervise Operations: Oversee the IPQA officer team to ensure flawless execution of line clearances, process monitoring, and in-process quality checks (IPC) across manufacturing and packaging.
• Resource Allocation: Manage shift rosters, allocate tasks, and provide ongoing technical training and competency assessments to the IPQA team.

2. Quality Management Systems (QMS) & Investigations

• Deviation Management: Lead the documentation, investigation, and risk assessment of manufacturing deviations, non-conformances, and processing incidents.
• Root-Cause Analysis (RCA): Utilize tools like Fishbone, 5-Whys, and FMEA to identify true root causes and design robust Corrective and Preventive Actions (CAPA).
• Change Control & Market Complaints: Review and assess change controls related to shop-floor processes or equipment. Assist in investigating market complaints related to manufacturing defects.
• BMR/BPR Verification:
• 4. Audit Readiness & Compliance
• Regulatory Inspection Facilitation: Serve as a frontline subject matter expert (SME) during internal, client, and regulatory audits (USFDA, MHRA, etc

5. Validation & Qualification Oversight

• Process Validation: Oversee IPQA monitoring during process validations, cleaning validations, and equipment qualifications (IQ/OQ/PQ).
• Protocol Review: Review and approve sampling plans, validation protocols, and report summaries from an IPQA perspective.

Job Requirements & Qualifications

• Education: B.Pharm / M.Pharm (highly preferred) or
• Experience: 9 to 15 years of core IPQA experience in a regulated commercial formulation facility

Contact - Praveen Kumar

Mail: [email removed]

Mobile: [phone removed]