Overview
Quality Auditor Jobs in Werthenstein, Kanton Luzern, Switzerland at MSD Switzerland
Location: Werthenstein
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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Title: Quality Auditor
Company: MSD Switzerland
Location: Werthenstein, Kanton Luzern, Switzerland
Category: Quality Assurance – QA/QC, Healthcare
