QA/QC Manager | Antwerp Area
For a global health care company specialized in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, we are looking for a QA/QC manager.
For the RA/QA department, due to further growth there will be a split in a RA/vigilance department and a QA/QC department (BENE). Related to this change we are looking for a QA/QC Manager. The QA team consists of a QA officer and a QA assistant whom will directly report to the QA/QC Manager. He/she will report directly to the General Manager.
Main tasks and responsibilities:
- Prepare and coordinate the administrative releases of the pharma products
- QC of locally outsourced activities (e.g. re-labeling) and internal GDP/ISO 9001 related activities
- Supplier qualification/maintenance
- Team meetings with the QA officer and assistant
- Motivate the QA team
- Join international QA meetings
- Participate in the maintenance of the local QMS (quality management system) and the coordination & follow-up of implementation of global SOP’s into local QMS
- Follow-up & documentation of events & change controls in the companies dedicated database
- Participate in the preparation of management reviews
- internal and/or external audits
- Preparation & follow-up of audit reports
- Follow-up of CAPA’s
- Depending on background and experience, act as deputy-RP
- Contribute in specific QA topics (e.g., product recalls, product quality complaints, exception reporting, …)
- Regular consultations with the RA/vigilance Director in QA related and other related topics
- Degree of pharmacist or master in pharmaceutical sciences (alternatively, a university background in life sciences with relevant working experience)
- Prior experience in Quality Assurance (including auditing), especially in the pharma sector or medical device sector, preferably more than 7 years
- Familiar with GMP, GDP, ISO 9001, HACCP regulations
- Proficient in Dutch and English (knowledge of French is an asset)
- Innovative, pro-active, customer oriented, team player.
- Accurate and precise with the ability to plan activities and meet deadlines
- Analytical, someone who likes to go to the essence of things and does not give up easily, attention to details
- High level of accountability and flexibility to respond to changes.
- PC literate: Word, Excel, PowerPoint, Lotus Notes
- Excellent verbal and written communication skills