Quality Assurance (QA) GMP Compliance Expert
Prismond Group SA
Zurich, Switzerland
vor 6 Tg.

Role & Responsibilities

In your role as a Consultys Compliance expert, you are supporting our clients and project teams by :

Harmonization of (Global) Quality Management Systems

Gap Analyses of the Q-Manuals against relevant Guidelines and Regulations

Developing and implementing QMS (Policies / SOPs) improvements of our clients

Review and correction of SOP landscapes

Writing of Global Quality Standards

Ensure complied documentation systems of our clients

Writing Quality risk management (QRM) concepts with the corresponding SOPs, templates and tools

Conception and Implementation of Supplier Quality Agreements

Handling of Change Control Requests, Non-Conformities and CAPAs, ensuring their adequate and timely closure from QA perspective

Supplier and Internal Audits including Mock-Inspections

Planning and moderation of QA workshops and training events

Support tech transfer and analytical method transfer activities

Position Requirements

University degree in Quality, Engineering, Sciences or another relevant discipline

At least 2-3 years of experience within a GMP-regulated environment, preferably in the Pharmaceutical or Medical Devices industry

Broad working knowledge of Quality Management Systems, cGMP and ICH Q9 regulations; basic understanding of manufacturing and supplier process

Analytical and structured working style; strong attention to detail

Ability to effectively work as part of a multidisciplinary, international team

Fluency in English is required, German, French or Italian would be a plus

Hands-on personality, with flexibility and dedication to maximize our client s value

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