QC compliance officer
Onze klant in de regio Wetteren is een gerenommeerd farmaceutisch bedrijf. Ze zijn actief in ontwikkeling en productie van fine chemicals voor de farmaceutische industrie.
Momenteel zoeken zij een QA compliance officer
You play a key role in the 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). This includes:
- Analysing 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.
- Contribute to the re-design of existing procedures and SOPs by making them more lean, transparant and harmonized throughout the different analytical labs.
- 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.
· 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.
015 445 880
015 445 880