QA (Qualification & Validation) Supervisor

Role Purpose

To supervise and ensure effective execution of qualification and validation activities for facilities, utilities, equipment, processes, and computerized systems, ensuring GMP compliance and readiness to support pharmaceutical manufacturing operations.

Role Description

• Supervise execution of DQ, IQ, OQ, and PQ activities for production equipment, utilities, and facilities in accordance with approved protocols and GMP requirements.
• Supervise process validation, cleaning validation, batch validation, and related lifecycle validation activities.
• Coordinate and supervise media fill and aseptic validation activities together with Production and QA1 (QMS & GMP Compliance).
• Supervise execution of Computer System Validation (CSV) activities for GMP‑relevant computerized systems in coordination with IT and Engineering.
• Review validation protocols, raw data, and reports for completeness, accuracy, and compliance before submission to QA2 Manager.
• Ensure proper handling and documentation of deviations, discrepancies, and changes related to qualification and validation activities.
• Coordinate daily qualification and validation activities with Production, Engineering, QA1, QC, and external vendors.
• Support internal audits, external audits, and regulatory inspections related to qualification and validation.
• Supervise and guide QA2 Specialists and Staff, including task assignment, monitoring progress, and on‑the‑job coaching.
• Ensure qualification and validation activities are executed on schedule without compromising GMP compliance.

Required

• Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, Microbiology, Chemistry, Chemical Engineering, or related scientific fields.
• 5–8 years of experience in qualification and validation activities within the pharmaceutical or biopharmaceutical industry.
• Hands‑on experience in equipment, utility, and facility qualification (DQ/IQ/OQ/PQ).
• Solid understanding of GMP requirements related to qualification, validation, and CSV.
• Proficiency in English (written and spoken).

Preferred

• Experience working in biopharmaceutical manufacturing environments.
• Experience supporting media fill, aseptic validation, and CSV.
• Experience supporting facility startup, expansion, or technology transfer projects.
• Experience supervising or guiding junior staff in validation activities.

• Multinational Company Environment
• SK Management Work Culture
• Social Insurance Fully Paid by Company
• Private Insurance Fully Paid by Company
• Lunch box & Snack box
• Employee Shuttle bus
• Annual Bonus based on Performance