Senior Executive - QA Validation

Enzene Biosciences Ltd.; Pune District; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Enzene Biosciences Ltd. is seeking a QA Validation professional to lead qualification activities for equipment, instruments, AHUs, and aseptic filling operations. The role supports deviations, CAPAs, change controls, and regulatory inspections across USFDA, EU, TGA, WHO, and other global agencies.

You will ensure data integrity, maintain the Validation Master Plan, and collaborate across Production, Engineering, QC, and Regulatory teams to drive improvements and ensure continuous compliance.

Qualifications

• 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.
• 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

Responsibilities

• 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.
• 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.
• Review SOPs, protocols, and reports related to validation activities.
• Drive continuous improvement initiatives to enhance validation efficiency and compliance.

Skills

QA Validation

Validation lifecycle

Regulatory audits

Data integrity

Cross-functional collab

Documentation

cGMP knowledge

Education

M.Sc or M.Pharm (full time)

Job description

• Plan, execute, review, and approve equipment and instrument qualification activities includingDQ, IQ, OQ, and PQin compliance with regulatory guidelines.
• Ensure effective execution ofAHU qualificationand HVAC validation activities.
• Prepare, review, and maintain validation documentation as per approvedValidation Master Plan (VMP).
• Support validation of critical utilities, systems, and processes related to biopharmaceutical manufacturing.

Quality Systems & Compliance -

• Ensure validation activities are aligned with theQuality 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 includingUSFDA, EU, TGA, WHO, and other global agencies.
• Prepare responses to audit observations related to validation and qualification.

Manufacturing & Operations Support -

• Provide QA validation oversight foraseptic filling operationsand associated equipment.
• Collaborate with Production, Engineering, QC, and Regulatory teams for validation activities, process improvements, and technology transfers.
• 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 yearsof experience inQA Validationwithin 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 ofbiopharmaceutical productsand cGMP requirements.
• 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