Executive & Senior Executive – Quality Assurance (IPQA)
Assistant Manager & Deputy Manager – 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: PraveenKumar.Gullipalli@aurobindo.com
Mobile: 9100968074
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: PraveenKumar.Gullipalli@aurobindo.com
Mobile: 9100968074