Senior Executive - QA Validation

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