Key Responsibilities

Validation &

- Qualification -

- Plan, execute, review, and approve equipment and instrument qualification activities including DQ, IQ, OQ, and PQ in compliance with regulatory guidelines.

- Ensure effective execution of AHU qualification and HVAC validation activities.

- Prepare, review, and maintain validation documentation as per approved Validation Master Plan (VMP).

- Support validation of critical utilities, systems, and processes related to biopharmaceutical manufacturing.

Quality Systems &

- Compliance -

- Ensure validation activities are aligned with the Quality Management System (QMS) and regulatory requirements.

- Participate in deviation investigations, CAPAs, change controls, and risk assessments related to validation.

- Maintain validation lifecycle approach and ensure data integrity and compliance.

Audit &

- Regulatory Support -

- Support and face regulatory inspections and customer audits including USFDA, EU, TGA, WHO, and other global agencies.

- Prepare responses to audit observations related to validation and qualification.

Manufacturing &

- Operations Support -





- Provide QA validation oversight for aseptic filling operations and associated equipment.

- Collaborate with Production, Engineering, QC, and Regulatory teams for validation activities, process improvements, and technology transfers.

Documentation &

- Continuous Improvement -

- Review SOPs, protocols, and reports related to validation activities.

- Drive continuous improvement initiatives to enhance validation efficiency and compliance.

Qualifications &

Experience -

- M.Sc or M.Pharm (full time)

- 6-9 years of experience in QA Validation within the biopharmaceutical industry.

- Solid experience with validation of equipment, instruments, AHUs, and aseptic filling operations.

- Hands-on experience with regulatory audits (USFDA, EU, TGA, etc.).

- In-depth knowledge of biopharmaceutical products and cGMP requirements.

Key Competencies -

- Strong understanding of cGMP and regulatory guidelines

- Expertise in validation lifecycle management

- Excellent documentation and compliance skills

- Audit readiness and inspection handling

- Cross-functional collaboration

- Analytical thinking and attention to detail

📌 Senior Executive - QA Validation (Pune)
🏢 Enzene Biosciences
📍 Pune