QA (QMS & GMP Compliance) Specialist & Staff

Role Purpose

To establish, operate, and continuously improve the Quality Management System (QMS) and GMP compliance framework by managing documentation, change control, deviation, CAPA, training systems, and supplier quality processes to ensure regulatory‑compliant pharmaceutical manufacturing operations.

Role Description

• Operate and maintain the Quality Management System (QMS) in accordance with GMP, internal policies, and regulatory requirements.
• Prepare, review, revise, and control quality documents, including SOPs, product specifications, batch records, and quality forms.
• Manage document control lifecycle, including issuance, revision, distribution, archival, and retrieval.
• Execute and monitor change control, deviation management, and CAPA processes, including documentation, tracking, and effectiveness review.
• Support training management, including training planning, scheduling, training matrix maintenance, and training record control.
• Support and execute supplier evaluation and qualification activities from a QMS perspective, including documentation review and follow‑up.
• Support internal audits, external audits, and regulatory inspections, ensuring QMS readiness and completeness of documentation.
• Support implementation and maintenance of Contamination Control Strategy (CCS) documentation and governance.
• Support technology transfer activities by ensuring QMS readiness, documentation alignment, and compliance during changes or scale‑up.
• Coordinate closely with QA, QC, Production, Engineering, and other departments to ensure consistent GMP implementation.

Required

• Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, Microbiology, Chemistry, Chemical Engineering, or related scientific fields.
• 1-5 years of experience in QMS establishment and/or GMP compliance within the pharmaceutical industry.
• Solid understanding of GMP principles, QMS processes, and documentation systems.
• Proficiency in English (written and spoken).

Preferred

• Experience working in QA Department within the biopharmaceutical industry.
• Experience supporting initial setup and operation of QMS in a newly constructed biopharmaceutical facility.
• Experience in establishment and management of Contamination Control Strategy (CCS).
• Experience supporting technology transfer processes.
• Holder of Pharmacist License (STRA).

• 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