Quality Complaint Expert (대전 바이오 공장, 3년 이상의 제약/바이오 Quality 경력) at The businesses of Merck KGaA, Darmstadt, Germany

Daejeon, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

19 Mar, 26

Salary

0.0

Posted On

19 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Analytical Testing, Troubleshooting, Data Integrity, Root Cause Analysis, CAPA Plans, Technical Writing, Interpersonal Skills, Problem Solving, Attention to Detail, Teamwork, Microsoft Office, eQMS, Pharmaceutical Sciences, Life Sciences, Biotechnology

Industry

Pharmaceutical Manufacturing

Description

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. Overall Objectives of the Position The Quality Complaint Expert will support the establishment of the APAC Quality Investigation Center and manage the full operation of customer complaint investigations in a timely manner. The Quality Complaint Expert will conduct analytical tests on locally returned products, document the results appropriately in the Complaint Management System to facilitate customer responses, and assist in basic troubleshooting of received issues. Your Role Safely set up the new facility and qualify and maintain lab test equipment throughout its life cycle, including installation, operational qualification, and preventive maintenance. Manage complaint returns from local customers in accordance with Standard Operating Procedures. Conduct analytical tests on returned materials for complaint investigations. Routinely review and verify test data for accuracy and reliability to ensure data integrity. Prepare documentation, including customer reports for complaint investigations, and record the data in the Quality Management System according to internal procedures and customer-specific demands. Communicate and collaborate effectively with manufacturing sites to jointly perform root cause analysis and develop CAPA plans. Regularly assess the overall performance of the Quality Investigation Center and conduct trend analysis of complaint investigation results. Review and revise controlled documents as appropriate to maintain up-to-date procedures and meet customer expectations. Support site inspections and customer visits as required. Maintain a sufficient inventory of materials necessary for daily operations. If necessary, support adjacent QA groups within the quality management system. Participate in sustainability efforts and proactively identify and report safety, quality, and productivity concerns, including hazardous conditions or behaviors observed in the working environment and on site. Who You Are Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, or a related discipline. Over 3 years of experience in the pharmaceutical, life science, biotechnology, or medical device industry. Experience with FT-IR, UPLC, and integrity testing for single-use assemblies and process filters (Bubble point, Diffusion test) is a plus. A high degree of accuracy and attention to detail, along with excellent interpersonal, oral, and written communication skills in English. Excellent problem-solving and organizational skills; attentive, careful, and meticulous, with strong teamwork abilities. Technical writing skills for investigation summaries. Basic computer skills, with familiarity with Microsoft Office applications and eQMS preferred. •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!

Responsibilities

The Quality Complaint Expert will manage customer complaint investigations and conduct analytical tests on returned products. They will also prepare documentation and collaborate with manufacturing sites for root cause analysis.