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Compliance Expert

Michael Bailey Associates - UK Contracts

Posted on Mar 8, 2021 by Michael Bailey Associates - UK Contracts

Stein, Aargau, Switzerland
Research
1 Apr 2021
Annual Salary
Contract/Project


Compliance Expert


One of our Large Pharmaceutical Clients based in Switzerland are currently looking for a Compliance Expert.


FLUENT GERMAN IS COMPULSARY


The successful candidate for the Complaince Expert vacancy will have the following responsibilities:


* Maintain and ensure general QA-oversight of all activities of the related Process Units (PUs) (with regard to products and general Quality Systems) and ensure general GMP-Compliance
* Participate in self-inspections and support inspections from health authorities on site
* Maintain relevant SOPs, support for GMP-Training
* Compile Annual Product Reviews (APRs)/Product Quality Reviews (PQRs) in accordance with GMP-requirements. Ensure that related follow-up activities are defined, carried out and reported.
* Review and approve Validation/Qualification protocols & reports (process validation, cleaning validation, equipment qualification), including associated risk assessments and deviations.
* Lead the evaluation and implementation phases of change requests, considering the most effective implementation strategy, priorities and regulatory requirements. Ensure GMP-compliant documentation, evaluation and implementation of changes. Proactively lead and follow up changes with all involved partners.
* Review and approve Master Batch Records, Standard Operating Procedures (SOPs) and other GMP-relevant documents


Initial experience in quality control/quality assurance or in the manufacturing of pharmaceutical drug products

FLUENT GERMAN IS COMPULSARY


Michael Bailey International is acting as an Employment Business in relation to this vacancy.




Reference: 1121247405

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