Description

We are looking for an experienced Quality Assurance Consultant (GMP/GDP) to work on a 12 months contract with possibility for extension.

Our client is a leading pharmaceutical company based in Switzerland. The successful candidate will be responsible for developing and implementing a standardized QMS across EU affiliates aligned with HQ QA requirement.

The ideal candidate will have experience in QA and PV field as well as GMP/GDP and QA.

 

Responsibilities

* Develop, maintain and drive compliance of the Affiliate Quality Management Systems against the company’s Quality Policies, industry standard and local PV, GMP/GDP related regulatory requirements

* Manage Affiliate documentation and training record within company Quality System

* Review and approve local (GxP related) standard documentation and develop local Quality related procedures as appropriate, in accordance with HQ QA principles and processes.

* Ensure the provision of appropriate quality related training for regulated activities in affiliates and monitor training compliance.

* Ensure appropriate and timely management of non-conformances related to relevant GxP (PV, GMP/GDP): change controls, internal and external CAPAs, Quality Events, deviations.

* Monitor quality system performance versus local quality relevant GxP requirements

 

Requirements

* Graduate Degree in Pharmacy, or other scientific or health related fields

* Experience in QA and PV field as well as GMP/GDP and QA

* Experience in regulatory inspections management, interactions with health authorities.

* In-depth knowledge of PV regulations and of GMP/GDP requirements

* Able to manage and resolve technical and tactical issues according to departmental/company procedures and regulations.

* Stakeholder’s management

* Quality Risk Management

* Fluent in English – German