Quality Assurance Specialist

Vor 7 Tagen


Luzern, Luzern, Schweiz Merck Gruppe - MSD Sharp & Dohme Vollzeit
Job Description

At Merck Gruppe - MSD Sharp & Dohme, we are committed to inventing for life by bringing forward medicines and vaccines that make a significant impact on people's lives. Our Research & Development facility is at the forefront of this mission, and we are seeking a highly skilled Quality Assurance Specialist to join our team.

The successful candidate will be responsible for supporting the development programs for our biologics portfolio, ensuring the reliable availability, quality, and regulatory compliance of biologics supplies produced at our facility. Key requirements include developing and implementing effective compliance and business processes with a strong operational focus aligned with business drivers.

  • Provide Quality Assurance (QA) support for in-house manufacturing programs, including compliance monitoring of manufacturing related activities, preparing and performing QA review of batch release documents, and acting as QA approver for change controls, deviations, and Corrective and Preventive Actions (CAPAs).

  • Support campaign readiness by releasing starting materials and incoming goods.

  • Participate and support quality-on-the-floor initiatives.

  • Assist in the creation and maintenance of QA policies, Standard Operating Procedures (SOPs), and reports in line with site/global requirements.

  • Maintain a proficient level of knowledge related to specialized areas of technical expertise.

  • Participate and support risk management activities in line with relevant guidance and best industry practice.

  • Work collaboratively to foster strong relationships with management and colleagues to drive a safe and compliant culture in our Research & Development facility.

  • Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.



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