Description
Pharma QA GMP/ISO AuditorDivision: Pharma QA
Location: Central Switzerland
Job: Full Time
Employment: Contract
Job Description
This is your chance to be part of a global, well established and innovative environment. Our client, one of the leading pharmaceutical and chemicals companies in the world is currently seeking a Pharma GMP Auditor to perform GMP audits to assist the team.
As a Pharma QA GMP/ISO Auditor you are required to perform GMP audits according to the Quality System and Standards & the current GMP regulations to ensure a high product quality and compliance with all applicable regulations. Your responsibility includes the manufacturing sites, non-manufacturing sites, quality systems, development centres, contract manufacturers and suppliers.
- Plan and perform audits according to the internal requirements. Such as; routine GMP surveillance audits and pre-qualification audits
- To provide appropriate escalation to responsible use and support direct follow-up to Quality Guideline for Management Escalation and field methods
- To consider evaluating the appropriateness of reaction (CAPA) plans to insights in collaboration with follow-up charge (FURP) and Audited (Quality responsible person QARP)
- Ensures that all have the appropriate experience and training of GMP auditor, to perform the auditing function. Provide GMP compliance and GMP trainings, support compliances activities
- You retain current knowledge of the requirements and best practices and elaborate auditing policy
- Graduate degree in, Chemistry, Pharmacy, Microbiology, or another related science
Requirements
- Excellent oral and written English communication skills, German desirable
- Technical knowledge in medical technology development and manufacturing
- Available to travel approx. 30% of the time
- Minimum of 3 years' experience of auditing, inclusive preferably Auditor certification by a recognized security organization as industrial ASQ and an excellent knowledge of the regulatory requirements.
- Minimum 5 years of experience in Pharmaceutical Industry
- Operational experiences such as manufacture, quality control / quality management, development, or other relevant experience includes, for example working on a regulatory health authorities
For more information on this or other opportunities, please send me your CV or please contact Sabina Keel at Real Staffing on
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