IPQA Lead (Packing) - Quality Assurance

We are looking for a potential candidate for the role of IPQA (Packing) Lead for Unison Pharmaceuticals, Unit III.

Experience : 6-15 Years

Current Location : Moraiya, Ahmedabad

Industry : OSD (Pharma)

Job Role :

1. IPQA Documentation

• Receive MFC and MPC from the R&D team and share with the team for preparation of packing-related BMR and BPR.
• Review and approve prepared BMR/BPR, ensuring it aligns with packing requirements, and obtain approval from the QA Head.
• Review and approve executed packing BMR/BPR to ensure compliance with procedures.
• Review and approve temperature mapping protocols and reports specific to packing areas.
• Review and approve documentation related to breakdowns and preventive maintenance of packing equipment.
• Conduct timely reviews of equipment audit trails and alarm verifications in packing operations.
• Review and approve product recipes and settings in PLC and SCADA systems relevant to packing operations.
• Review SOPs related to packing processes and QA for adherence to compliance standards.

2. Training and Development

• Facilitate regular training and evaluations on SOPs, protocols, and general awareness for staff working in packing areas.
• Ensure competency of the packing team through periodic assessments and requalification.

3. GDP and GMP Compliance

• Ensure all personnel in the packing area are trained and qualified for their roles.
• Monitor real-time packing activities to ensure compliance with GDP and GMP standards.
• Verify and document adherence to approved packing procedures and practices.

4. Process Validation

• Review and approve packing process validation protocols and reports.
• Ensure validation activities meet regulatory and quality standards.

5. Cleaning Validation

• Review and approve cleaning validation documents for packing lines, including protocols, reports, sampling plans, surface area assessments, and equipment matrices.
• Assess the impact of changes to packing equipment and materials on cleaning validation.

6. Qualification

• Review and approve qualification protocols and reports related to packing equipment, AHU systems in packing areas, and utilities such as compressed air.
• Approve computer system validation documents for packing operations.

7. Calibration Activities

• Ensure monthly calibration of balances and scales in the packing area.
• Review and approve quarterly calibration reports for IPQA instruments used in packing, such as label scanners, vision systems, and torque testers.

8. Quality Management System (QMS)

• Investigate deviations, market complaints, packing process investigations, and change controls related to packing.
• Review and approve CAPA plans and product recall documentation.
• Share investigation reports with the Plant Head and QA Head for final review and approval.

9. Team Management

• Allocate tasks to the IPQA team based on packing schedules and priorities.
• Ensure real-time documentation and compliance within the packing area.
• Lead and mentor the IPQA team in packing operations, fostering a culture of quality and compliance.

Interested candidates can share their updated CV on sandipnair@unisonpharmaceuticals.com