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QA / QC Compliance Officer

SIRE Life Sciences®

Belgium, zagranica

SIRE Life Sciences®

QA / QC Compliance Officer

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Oost-Vlaanderen Belgium.

The Client is a leader in the pharmaceutical industry, a global manufacturer of high-quality pharmaceuticals.

ROLE DESCRIPTION

In this role you will be responsible in further development, maintenance and optimization of the company’s global management system (GMS) related to (analytical) laboratory operations (covering both quality control and analytical development)

RESPONSIBILITIES

- Analyzing existing or new analytical business processes and make sure they are adequately reflected in procedures and SOPs and consistent with current guidelines and industry best practices.
- You represent the analytical departments in cross-functional compliance teams where you interact with compliance collegues from other deparments in order to make sure the overal approach to compliance is alligned and consistent througout the entiry company
- You actively contribute to the establishment and implementation of lab compliance related CAPAs resulting from audit observations (external and internal) or from adverse events (e.g. deviations). This includes:
- Investigation the audit observation or adverse event
- Define and discuss CAPA proposals with CAPA owners and the managers of the different labs
- Keep track of CAPAs until closure
- You provide support in case of audits (internal and customer audits) and inspections for health autorities.
- You play an key role in training programs related to laboratory compliance.

REQUIREMENTS

- You possess a master degree in Sciences.
- You are familiar with analytical laboratory environments and have occupied QC/QA functions preferably within the pharma or related industries ( 3 to 5 years)
- You possess a proven track record of project and change management skills.
- You have an analytical mind and are able to translate complex processes into clear, efficient and compliant procedures
- You are an excellent communicator in Dutch and English (spoken and written).
- You organise your work efficiently and know how to deal with pressure and deadlines.
- You possess good IT-skills (eg Outlook, Word, Excel, Powerpoint,…). Preferable you also have knowledge of SAP and Sharepoint.
- Proven experience with Operational Excellence (Lean/sigma) is an asset.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.

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SIRE Life Sciences®

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