QA specialist - focus on DSP
For our biopharmaceutical site, where we develop and manufacture biopharmaceutical products for both clinical trials and commercial production, we are looking for a QA specialist with a background in cell culture and downstream processing. In this role you will support our organization in handling quality matters and participate in the set-up, maintenance and improvement of quality related processes. You will be responsible for reviewing GMP related documents such as batch records, procedures, work instructions as well as related change controls, CAPAs and deviations. We focus on continuous improvement and lean implementation to continuously enhance our production facility.
Your responsibilities include:
- Reviewing of batch documentation;
- Handling of deviations, CAPA's and change controls ;
- Supporting production departments with GMP related projects ;
- Ensuring appropriate and lean implementation ;
- Reviewing and approving GMP documentation such as validation protocols and reports, risk assessments, procedures, work instructions; all in line with the applicable corporate procedures and policies;
- Reviewing regulatory submission documents ;
- Performing internal and external audits of departments and suppliers respectively.
- MSc level of experience and education in Life Sciences;
- A minimum of 3 years work experience in the biopharmaceutical industry in a cGMP environment; in combination with relevant quality experience, e.g. QA, Production, Process Development, Technical Operations ;
- Experience with cell culture and downstream processing operations is key ;
- Knowledge of GMP guidelines and regulations in the scope of biopharmaceutical industry;
- Experience in transferring processes from early to late clinical phase and subsequent to commercial phase including PPQ and regulatory submission is a strong plus .
Are you ready for a new challenge as QA specialist at an international organisation with plenty of room for own initiative and development? Then get in touch with Gaia Brouwers for more information or to apply directly: 020 530 5888 / G.brouwers [@] progressiverecruitment.com.