IPQA Section Head - Sterile at Indoco Remedies · South…

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.
• Good 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.