QA Validation Specialist

Roles & Responsibilities

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.