Beschreibung
Compliance Manager (m/f/d)
Reference: -en
Start: asap
Duration: 16 MM++
Main tasks:
- 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
Main qualifications
- (Technical) University/academy degree in chemistry, pharmacy or equivalent
- German: fluently spoken/written
- English: very good knowledge spoken/written
Main advantages:
- A highly motivated team and an open way of communication
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Zlatan Mujagic
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