QA Supervisor at The businesses of Merck KGaA, Darmstadt, Germany

Daejeon, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

21 Feb, 26

Salary

0.0

Posted On

23 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP Compliance, Documentation Management, Training Management, Audit Program Management, Supplier Management, Change Control, Deviation Management, CAPA, Quality Risk Management, Internal Audit, External Audit, Decision Making, Problem Solving, ISO 9001, Pharmaceutical Sciences, Life Sciences

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. 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. 내부 전보 확정 시 법인 이동이 필요한 경우, 퇴직급여 정산 또는 이전 절차 및 각종 사내대출 상환 절차가 필요할 수 있습니다. 내부 지원 시 해당 사항을 숙지하고 지원한 것으로 간주합니다. 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 QA Supervisor will ensure compliance with regulatory and corporate requirements by managing quality assurance tasks and activities. This includes maintaining documentation systems, training systems, and overseeing key quality assurance activities at the site.