Compliance Specialist
CK QLS are recruiting for a Compliance Specialist to join a leading pharmaceutical company at their site based in Stein on a contract basis until the end of August 2022. The role is offered on a 50% basis.
Compliance Specialist Role: The main purpose of the role will be to:
- Maintain and ensure general QA-oversight of all activities 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.
Further responsibilities will include:
- Leading 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.
- Reviewing and approving Master Batch Records, Standard Operating Procedures (SOPs) and other GMP-relevant documents.
Your Background: In order to be considered for this role, youwill be required to have the following qualifications, skills and experience:
- Relevant qualification within a Scientific discipline.
- Fluent German and English skills (spoken and written), this is essential.
- Previous experience in a QC or QAenvironment within the manufacturing or pharmaceutical drug product environment.
This is an excellent opportunity to join a leading pharmaceutical company.
Apply: For more information or to apply for this Compliance Specialist position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email jblackham@ckqls.ch, quoting job ref 50040.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.