대전 바이오 공장 신설 - QA Specialist (5년 이상, GMP, ISO)

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.  

Your role:
 

Overall Objectives of the Position

• The Quality Assurance specialist will entail ensuring compliance with all regulatory and corporate requirements in support of regulatory (ISO, EXCiPACT and applicable agencies), internal standard and customer expectations, by carrying out routine quality assurance and quality control tasks and activities.
• The Quality Assurance specialist will handle to Documentation System, Production Quality, Training System building-up and operation to ensure the systems compliance with all Domestic and Global regulatory and corporate requirements.
• The Quality Assurance specialist will conduct audits of manufacturers, laboratories, supplier, etc. to assure compliance to current standards/ISO. And 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.

Responsibilities

• Check production line daily and control for the whole production process to ensure the whole production process control can meet with site procedures.
• Prepare the quality related procedure according to company requirement.
• Prepare the SOPs for quality management system (Document, Deviation, CAPA, Change control etc..)
• Review and approve the SOPs
• Build up the quality related electronic systems
• Participate in GMP training program in the plant to ensure the training management meeting the requirements of site and global.
• Review the validation and qualification document and Investigation of quality issue
• Deviation/change control management
• Annual product review
• Ensure to fulfill the KPIs of QA
• Actively participate in quality culture building and quality related activities
• Actively report quality related events and participate in continuous quality improvement activities.
• Manage all quality audit aspects of Suppliers, Repackagers, Distributors, Warehouses, Contract Laboratories as appropriate and timely provide audit report and supplier CAPA, and follow up supplier CAPA until the final audit

Who you are:

Qualification:

• 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 preferred.
• New project experience and build-up of quality management system are preferred.
• Familiar with GMP regulations/guides and quality management process.
• Fluent in English.
• Result orientation, accuracy and reliability as a must.
• 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 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!
 
Apply now and become a part of our diverse team!