Sterile Formulation.

Section Head IPQA- Quality Assurance (QA)

Experience

8 to 12 Years

Qualification

- B.Pharm / M.Pharm

Key Responsibilities

Sterile IPQA Operations

- Lead and supervise all IPQA activities in Sterile Manufacturing (Injectables, Ophthalmics, BFS, Lyophilization, etc.).
- Ensure line clearance, batch start-up, in-process checks, and stage-wise verification are performed as per approved procedures.
- Monitor aseptic practices and GMP compliance on the shop floor.
- Review and approve IPQA documentation and manufacturing records.
- Ensure compliance with environmental monitoring and personnel qualification requirements.

Quality Compliance
- Ensure adherence to cGMP, GDP, ALCOA+, and data integrity principles.
- Participate in internal audits, regulatory inspections, and customer audits.
- Support investigation of deviations, OOS, OOT, market complaints, and CAPA implementation.
- Review change controls, risk assessments, and quality events related to sterile manufacturing.

Documentation
- Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and logbooks.
- Ensure timely review and approval of SOPs, protocols, reports, and quality records.
- Maintain documentation in compliance with regulatory expectations.

Team Management
- Lead, mentor, and develop the IPQA team.
- Allocate manpower and manage shift-wise activities.
- Conduct training on GMP, SOPs, aseptic behavior, and quality systems.
- Monitor team performance and ensure competency development.

Cross-Functional Coordination
- Coordinate with Production, QC, Engineering, Warehouse, Validation, and Regulatory Affairs.
- Provide QA support during equipment qualification, process validation, media fills, and technology transfers.
- Participate in quality review meetings and continuous improvement initiatives.





Regulatory & Inspection Readiness
- Maintain inspection readiness at all times.
- Support audits by agencies such as USFDA, MHRA, EMA, WHO, ANVISA, and other regulatory authorities.
- Ensure timely closure of audit observations through effective CAPA.

Required Skills
- Strong knowledge of Sterile Manufacturing and Aseptic Processing.
- Thorough understanding of cGMP, GDP, and Data Integrity.
- Experience in handling regulatory inspections and customer audits.
- Strong leadership and people management skills.
- Valuable knowledge of deviation investigation, CAPA, change control, and risk management.
- Excellent communication, analytical, and problem-solving abilities.
- Proficiency in Microsoft Office and quality management systems.

Preferred Experience
- Experience in sterile injectables, ophthalmics, lyophilized products, or BFS manufacturing.
- Exposure to Annex 1 requirements and contamination control strategy (CCS).
- Experience with media fills, environmental monitoring, aseptic process simulation, and validation activities.
- Knowledge of electronic quality management systems (eQMS) and ERP/SAP is an advantage.

Key Performance Indicators (KPIs)
- Compliance with GMP and regulatory requirements.
- Timely completion of IPQA activities.
- Reduction in deviations and repeat quality issues.
- On-time closure of CAPAs and investigations.
- Audit readiness and successful regulatory inspections.
- Team productivity and training compliance.
- Documentation accuracy and batch release support.

Behavioral Competencies
- Leadership and decision-making
- Attention to detail
- Integrity and accountability
- Problem-solving mindset
- Effective communication
- Team collaboration
- Continuous improvement orientation

This JD is suitable for Section Head overseeing Sterile IPQA operations.

📌 IPQA Section Head - Sterile (South Goa)
🏢 Indoco Remedies
📍 South Goa