Manufacturing Pharmacist

• Experience with aseptic process and sterile injectable products in pharmaceutical or animal health industry
• English : Professional working proficiency

• 대한민국 관계 법령에 따른 약사 면허 소지자
• KVGMP 또는 KGMP관련 지식

• 무균주사제 생산 공정 경험자
• 영어 : working proficiency

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Manufacturing Pharmacist is responsible for oversighting overall production process to ensure local GMP compliance at Banwol manufacturing site. This position will act as Sterility Assurance expert to collaborate with cross-functional teams to develop and implement strategies, processes, and best practices to ensure overall aseptic process.

• →Oversight overall production process to ensure local GMP compliance.
• →Review and approve Master Batch Record, SOPs, change control and deviation process.
• →Respond GMP audit
• →Lead the design, implementation, and continuous evolution of the site-wide Contamination Control Strategy (CCS)
• →Provide technical oversight and strategic direction for aseptic, process, and sterilization validation programs
• →Lead investigations and resolution of contamination events, sterility failures, deviations, and CAPAs
• →Represent and defend sterility assurance programs during regulatory inspections and corporate audits
• →Mentor and develop technical talent while driving scientific rigor and risk-based decision-making across the organization

What You Need to Succeed (minimum qualifications):

• →Korean Pharmacist license required based on relevant Korean law
• →Good KVGMP or KGMP knowledge 
• →Strong problem-solving, root cause analysis skill

• Travel: Not required
• Location: Banwol, Korea

• 제조지시서, 기준서, 제조공정 표준작업지침서(SOP), 일탈, 변경 등 GMP문서 검토 및 승인
• 동물용 의약품등 취급규칙 제13조(제조관리자의 준수사항)에 따른 제조 공정 관리
• GMP 감사 대응
• 무균 주사제 제조 공정에 대한 오염관리 전략 수립: Contamination Control Strategy (CCS)
• 무균 공정 관련 일탈 조사 및 CAPA수립 관리