QA Validation Specialist

Primary Objective / Purpose
To uphold strict GMP compliance, safeguard documentation integrity, and govern the final batch release approval process.

Key Responsibilities
• Review and approve all validation protocols and reports.

• Conduct comprehensive batch record reviews.

• Govern deviations, investigations, and CAPA processes.

• Authorize the release of Engineering Run and PPQ batches.

• Perform internal GMP audits and readiness inspections.

Key Deliverables
• Batch disposition decisions

• Deviation & CAPA reports

• Validation approvals

Required Skills & Qualifications
• Degree in Science or Engineering.

• Extensive knowledge of cGMP regulations and quality systems.

• Experience with eQMS software (e.g., TrackWise, Veeva Vault).

• Strong auditing, problem-solving, and compliance mindset.

Skills

Performance Testing, Deviations, Science, Key Management, Investigation, validation protocols, Problem Solving, Auditing, Test Automation, Selenium, Batch Management