SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Oost-Vlaanderen Belgium.

The Company

A international pharmaceutical client who is driving by the commitment to patients. The client brings innovative products, services and solutions throughout people around the world.

Role Description

The Pharmaceutical Quality Officer is part of the Business Quality Department Benelux. He/she plays an important role in the implementation and maintenance of Quality Systems. He/she holds ownership of those systems and contributes to the continuous improvement of the Pharmaceutical Quality aspects of our business.
As a registered Responsible Person (RP) the Pharmaceutical Quality Officer Benelux

Responsibilities

- Act as local process owner for event and deviation management, CAPA management and change management systems
- Act as back-up for the Head of Quality, focussing on product quality complaint handling and product issue handling, recalls and field actions
- Assist in GxP inspections and audit preparation and provide support during actual inspection /audit execution
- Ensuring that new / revised quality management systems are implemented and maintained
- Guide the local Product Quality Review process, assuring compliance with the EU GMP guidelines and J&J Business Quality requirements
- Together with QA associate QMS, take leadership in document management processes.
- Act as primary contact for the European Distribution Center regarding batch version and batch status management
- Coordinating and performing promptly any recall operations
- Ensuring that relevant customer complaints are dealt with effectively
- Authorizing the return to saleable stock of any returned medicines

Requirements

- Preferably 2 years of experience in pharmaceutical or related industry, ideally with a mix of manufacturing / Distribution / QA operations experience.
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes and their relation to the marketing authorization process.
- Up-to-date knowledge of relevant pharmaceutical legislation, directives and guidelines, GMP/GDP and SOP’s.
- Ability to work independently, systematically and orderly with great accurateness.
- Strong analytical, communication and decision-making skills.
- Creative and pro-active team player.
- Thorough command of the Dutch, English and preferably French language.

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