QA Support Officer

Our client is a leading CMO organisation in the Netherlands, which is currently growing and therefore requires additional support from a QA Specialist for the production department.

You will be supporting the areas in quality systems, including production documentation, for the production department at the appropriate quantitative and qualitative level, in order to execute manufacturing activities according to international requirements as defined by FDA, EMEA, ICH, cGMP etc.

RESPONSIBILITIES:

- Responsible for timely preparation of batch documentation.
- Supports in quality actions related to Operations (actions related to deviations, internal and external audits, Change Control).
- Supports in quality improvement projects.
- Supports in training of Operations teams.

REQUIREMENTS:

- At least 3 years of relevant experience in a (bio) pharmaceutical company.
- Knowledge of pharmaceutical cGMP systems and relevant process unit operations (eg cell culturing, purification).
- Bachelor of Science (biology, biochemistry, chemistry).
- Expert in English, both in oral and written communication. Social and communication skills.
- Leadership and coaching skills.
- Pro-active attitude.
- Planning and organisation skills