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.
- Strong 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
