QA (Qualification & Validation) Specialist

1. Equipment Qualification

• Plan, execute, and review qualification activities (DQ, IQ, OQ, PQ) for DS production equipment such as Process Tanks, Chromatography systems, and UF/DF systems.
• Perform qualification for DP production equipment, including Aseptic Filling Machines, Lyophilizers, and supporting systems.
• Manage qualification of utility systems (HVAC, PW/WFI, Clean Steam, Compressed Air, Pure Steam, etc.).
• Prepare, review, and approve qualification protocols, reports, and related GMP documentation.
• Coordinate qualification activities with Engineering, Production, QC, and external vendors.

2. Validation

• Support and execute media fill validation to ensure sterility assurance compliance.
• Perform process validation and cleaning validation activities.
• Support batch validation, contaminant inspection validation, and media contamination testing.
• Execute and review CSV (Computer System Validation) in accordance with regulatory and data integrity requirements.
• Ensure validation activities comply with GMP, regulatory guidelines, and internal SOPs.

3. Compliance & Quality Support

• Support internal and external audits related to qualification and validation activities.
• Participate in deviation investigation, root cause analysis, and CAPA related to qualification/validation.
• Maintain qualification and validation lifecycle documentation.
• Support QA systems during commissioning, startup, and routine operation phases.

Required

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, Microbiology, Chemistry, Chemical Engineering, or related fields.
• 2–4 years of experience in qualification and validation within the pharmaceutical industry.
• Good understanding of GMP, validation lifecycle, and regulatory expectations.
• Proficiency in English (written and spoken).

Preferred

• Experience in biopharmaceutical qualification and validation.
• Experience supporting QA setup in a new biopharmaceutical facility (commissioning/start‑up phase).
• Holder of Pharmacist License (STRA).

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