About the role

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 -

Senior Executive - QA Validation