대전 바이오 공장 신설 - QA Expert (10년이상, Customer Audit, GMP 경력)

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Report to: QA manager

Overall Objectives of the Position

• The QA expert role will entail ensuring compliance with all regulatory and corporate requirements in support of regulatory and customer expectations, by carrying out routine quality assurance and compliance tasks and activities.
• The QA expert will manage to Documentation System, Training System, QMS system and operation to ensure the systems compliance with all Domestic and Global regulatory and corporate requirements.

Your Role:

• Responsible audit readiness and lead audit program for ISO, PAM /EXCiPACT, and customer inspection and self-inspection.
• Maintain SOPs and documents archiving in compliance with company quality requirements and applicable regulations.
• Manage eQA system such as Documentation System, Training System, QMS system and operation to ensure the systems compliance with all Domestic and Global regulatory and corporate requirements.
• Ensure key quality assurance activities are properly organized at site including but not limited to Supplier Management, Documentation, GMP training, Change Control, Deviation, CAPA, Quality Risk Management, Internal Audit and External Audit.

Who you are:

• Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, or a related discipline.
• A minimum experience of 10 years in the pharmaceutical, biotechnology or medical device in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
• ISO 9001 auditor certificate preferred.
• Audit program leading experience preferred (Customer audit)
• supervisory experience preferred
• Good decision-making and problem-solving capability.
• Fluent in English.

<유의사항>

• 여러분이 찾고 계시는 채용 포지션이 없으신가요? 그렇다면 인재풀(클릭))에 여러분의 이력서를 등록해주세요! 향후 인력 수요가 있을 경우 최우선으로 안내드리겠습니다.
• 지원 순으로 전형이 진행되며, 적합한 후보자 발견 시 채용이 바로 마감되오니 지원의사가 있으신 분들은 빠른 지원 바랍니다.
• 서버 안정성을 위해, 인터넷 익스플로러가 아닌 구글 크롬, 혹은 마이크로소프트 엣지를 통한 지원 바랍니다.
• 보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.
• 지원서의 기재사항이 사실과 다른 것으로 확인되거나 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 있습니다.
• 당사는 입사지원자에게 이전, 재직중인 회사의 영업비밀 또는 기밀정보를 당사 채용 및 업무 수행과정에서 사용, 활용하거나 유출하지 않도록 요구하며, 관련 서약서를 통해 이를 확인하고 있습니다.
• 만약 재직 회사의 영업비밀 침해 등 후보자님의 책임 있는 사유로 회사(머크)에 에 대한 법적 문제가 발생할 가능성이 있는 경우, 회사는 설사 채용된 이후라도 채용을 취소할 수 있습니다
• The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application.
• If there is a possibility of legal issues arising against the company (머크) due to a candidate's responsible actions, such as the infringement of trade secrets of their current employer, the company may cancel the hiring even after the candidate has been employed.
• "머크 코리아 채용" 카카오톡 페이지와 친구를 맺어 최신 채용 소식을 받아보세요! (카카오톡에 '머크 코리아 채용'검색 후 친구추가)

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

and become a part of our diverse team!