Job Description

QA/QC Manager | Antwerp Area

Belgium Pharmaceuticals
Posted by Luc Decat on 14/06/2019

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.

 

The function:

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

 

Profile:

  • 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

 

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