For our Swiss Clinical supply site, we are currently looking for a Temporary Quality Assurance Specialist who will support our Quality Operations and Compliance organization on clinical quality activities at the MSD Werthenstein site. The successful candidate will have accountability for Good Manufacturing Practice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance and drug product supply. The candidate will conduct Quality Assurance activities in support of the Compliance program and provide quality oversight for Site Operations and Systems. This includes reviewing and approving GMP documentation and managing various processes in the role of QA representative, such as calibration, equipment periodic reviews, logbooks, training, and site procedures.
As a Quality Assurance Specialist, you will be responsible for the oversight and support of certain quality assurance activities in the space of Quality Operations and Compliance.
This position will report to the Quality Systems Associate Director.
THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO: Conduct quality review and approval of GMP documentation (e.g. calibration activity documentation, equipment periodic review, logbooks, training plans and records, SOPs).
Support quality oversight activities under the responsibility of the Quality Operations and Compliance area (e.g. calibration, equipment periodic review, logbooks, management for training plans and training records, SOPs, quality on the floor).
Assure and maintain compliance with GMP regulations in the defined scope of work.
Provide support to projects and source areas as Quality Assurance Representative.
QUALIFICATIONS: BA/BS or higher academic education.
3+ years of experience in a regulated industry, preferably in pharmaceuticals, biotechnology, or medical technology.
Experience in conducting quality oversight activities.
Focus on quality and compliance.
Excellent communication skills and fluency in English.
This is a temporary role for six months. More information can be given on application.
Seniority level Not Applicable
Employment type Temporary
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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