QA Validation Specialist

REGIONAL ENERGY PTE. LTD.

Date: 4 days ago
City: Singapore, Singapore
Salary: SGD 6,000 - SGD 8,000 / mo
Contract type: Full time

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.

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