Manager / Senior Executive - QA Validation

Why This Role Matters

The Manager / Senior Executive – QA Validation plays a critical role in ensuring that biopharmaceutical manufacturing systems, utilities, and aseptic processes operate in full compliance with global regulatory standards. In highly regulated environments such as biologics and aseptic manufacturing, validation is fundamental to product quality, sterility assurance, and patient safety.
This role ensures that equipment, instruments, HVAC systems, and critical utilities are properly qualified and maintained throughout their lifecycle. By aligning validation practices with cGMP, regulatory guidelines, and internal Quality Management Systems (QMS), the position strengthens audit readiness and inspection confidence.
Through collaboration with Production, Engineering, Quality Control, and Regulatory teams, this role supports seamless technology transfer, process optimisation, and operational excellence. Ultimately, it safeguards compliance while enabling innovation within a biopharmaceutical manufacturing environment.

Job Description

The Manager / Senior Executive – QA Validation is responsible for planning, executing, reviewing, and approving validation and qualification activities across biopharmaceutical manufacturing operations. The role ensures that all validation activities follow regulatory expectations and internal quality standards.
The candidate will provide QA validation oversight for equipment, instruments, AHUs, HVAC systems, aseptic filling operations, and other critical utilities. The role includes active participation in audits, regulatory inspections, deviation management, CAPA implementation, and continuous improvement initiatives.
This position is suited for experienced QA Validation professionals with 6–9 years of experience in the biopharmaceutical industry and strong exposure to global regulatory inspections.

Key Features of the Role:

• Position: Manager / Senior Executive – QA Validation
• Department: Quality Assurance
• Industry: Biopharmaceutical Manufacturing
• Qualification: M.Sc / M.Pharm
• Experience Required: 6–9 years in QA Validation
• Strong exposure to aseptic filling and HVAC validation
• Hands-on regulatory audit experience (USFDA, EU, TGA, WHO)
• Focus on lifecycle validation and compliance excellence

Responsibilities

Validation & Qualification
• Plan, execute, review, and approve equipment and instrument qualification activities (DQ, IQ, OQ, PQ)
• Ensure effective execution of AHU qualification and HVAC validation
• Prepare, review, and maintain validation documents as per the approved Validation Master Plan (VMP)
• Support validation of critical utilities, systems, and manufacturing processes
• Maintain validation lifecycle management in line with regulatory expectations

Quality Systems & Compliance
• Ensure validation activities align with QMS and regulatory guidelines
• Participate in deviation investigations, CAPA management, change controls, and risk assessments
• Maintain data integrity and compliance across validation documentation
• Ensure ongoing cGMP compliance in all validation processes

Audit & Regulatory Support
• Support and face regulatory inspections and customer audits (USFDA, EU, TGA, WHO, and other agencies)
• Prepare responses to audit observations related to validation and qualification
• Maintain audit readiness at all times

Manufacturing & Operations Support
• Provide QA validation oversight for aseptic filling operations and associated equipment
• Collaborate with Production, Engineering, QC, and Regulatory teams
• Support technology transfer and process improvement initiatives

Documentation & Continuous Improvement
• Review SOPs, validation protocols, and reports
• Drive continuous improvement initiatives to enhance validation efficiency
• Strengthen compliance systems and process robustness

Required Qualifications

The ideal candidate is a detail-oriented validation expert with deep technical knowledge of biopharmaceutical manufacturing processes and regulatory compliance frameworks.

Educational Requirements:

• M.Sc in Life Sciences / Biotechnology / Microbiology or related discipline OR
• M.Pharm
• Strong academic foundation in pharmaceutical validation and quality systems

Experience and Skills:

• 6–9 years of experience in QA Validation within biopharmaceutical manufacturing
• Strong experience in equipment qualification (DQ, IQ, OQ, PQ)
• Hands-on experience in AHU and HVAC validation
• Expertise in aseptic filling validation oversight
• In-depth knowledge of cGMP and global regulatory requirements
• Experience handling regulatory inspections (USFDA, EU, TGA, WHO)
• Strong documentation and validation protocol review skills
• Experience managing deviations, CAPA, and change control processes
• Strong analytical and problem-solving abilities
• Excellent cross-functional collaboration skills
• High attention to detail and compliance-focused mindset

Salary Insights

Compensation will be competitive and aligned with industry standards based on experience and expertise in QA Validation within the biopharmaceutical sector. Candidates with regulatory inspection handling experience and aseptic validation exposure typically command strong market packages and growth opportunities within global pharmaceutical organisations.

Company Overview

Enzene is an innovation-driven biopharmaceutical organisation committed to advancing healthcare through cutting-edge science and robust quality systems. The company emphasises regulatory excellence, advanced manufacturing technologies, and a culture of continuous improvement.
At Enzene, employees are recognised as the organisation’s greatest asset. The company fosters a forward-looking culture powered by pioneers who are dedicated to transforming the pharmaceutical industry through innovation, operational excellence, and uncompromising quality standards.

FAQs

Q1. Is aseptic filling validation experience mandatory?
Yes, hands-on experience in aseptic filling operations validation is strongly preferred.

Q2. What regulatory exposure is required?
Experience handling inspections from USFDA, EU, TGA, WHO, or other global agencies is expected.

Q3. Is this role focused only on documentation?
No. The role includes active shop floor validation oversight along with documentation review.

Q4. What level of experience is suitable?
Candidates with 6–9 years of relevant QA Validation experience in biopharmaceutical manufacturing are ideal.

Q5. Does the role involve cross-functional coordination?
Yes, close collaboration with Production, Engineering, QC, and Regulatory teams is required.

Application Tips

• Highlight experience in DQ, IQ, OQ, and PQ qualification activities
• Mention AHU, HVAC, and aseptic validation exposure
• Provide examples of regulatory inspection handling
• Showcase deviation management and CAPA experience
• Demonstrate knowledge of lifecycle validation principles
• Emphasise cross-functional project coordination skills