Quality Assurance Expert
- Plans projects and possible measures for further development and improvement of supplier management, release processes for finished products, of corrective and preventive measures during production as well as specifications for the handling of deviations.
- Controls and monitors the implementation of planned measures in the above mentioned areas. Monitors quality standards of all products and initiates changes which are relevant in the area of responsibility.
- Responsible for formal review of batch records and release of batches in SAP and making decisions about internal holds when necessary.
- Responsible for feasibility studies and implementation WF’s and product transfers as quality expert.
- Responsible for customer questionnaires.
- Responsible for review of customer Quality Agreements and SSQ (Secondary Site Qualification, primary and secondary site -process in CompliantPro).
- Responsible for management of returned materials (resorting protocols and reports) when necessary.
- Participating on internal audits and GMP checks, on supplier audits from quality.
- Performs risk assessments with other departments for change controls or investigations.
Required education and experience
- Degree on Quality field or similar (minimum BSc but preferred MSc)
- Quality experience in an Engineering / Manufacturing environment 5-10 years (preferred Pharmaceutical Business, GMP knowledge)
- Knowledge of ISO 15378 / ISO 13485 and ISO 14644 standard, GMP, APQP, PPAP
- Good command of English
- Problem solving skills (OOS & deviation management)
- Experience regarding auditing (internal or supplier)
- Vas county