Operation QA Specialist (5년이상,제약/바이오 GMP QA operation 경험 필수)

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.  

Job Title: QA specialist

Report to: QA Manager

Job Overview:

• The Operation QA specialist will entail ensuring compliance with all regulatory and corporate requirements in support of regulatory (ISO, EXCiPACT and applicable agencies), internal standard (Merck) and customer expectations, by carrying out routine quality assurance and quality control tasks and activities.
• The Operation QA specialist will handle to deviation, CAPA, change control to ensure the QMS systems compliance with all Domestic and Global regulatory and corporate requirements.
• The Operation QA specialist will resolve quality concerns and implement quality improvements by meeting with other department Managers, Supervisor to assure current methods, procedures or SOP’s meet current standards.

Your Roles:

• Partner with Operations teams to support production activities related Merck products in a GMP manufacturing facility.
• Perform review of production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies
• Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
• Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
• Author and revise Quality departmental documents.
• Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies.
• Review and check the batch records
• Participate in continuous improvement activities.
• Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment.
• Supports site inspections and inspection readiness activities. Ensure the site is audit ready.
• Support data integrity efforts.
• Maintain a sufficient inventory of materials necessary for daily functions.
• If necessary, support adjacent QA groups with record issuance and management.

Who you are:

• Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, or a related discipline.
• At least 5 years of working experience in an international pharmaceutical or biological GMP/ISO environment with GMP/ISO experience. Aseptic experience is highly preferred
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills
• Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability.

<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 대한 법적 문제가 발생할 가능성이 있는 경우, 회사는 설사 채용된 이후라도 채용을 취소할 수 있습니다

•The company reserves the right to withdraw the offer if it discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application.

• We require candidates not to use, exploit, or leak the trade secrets or confidential information of their previous or current employers during our hiring and work processes, and we confirm this through relevant declarations.

• 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!
 
Apply now and become a part of our diverse team!