Menu

Vacancies

❮  Back to jobs overview

Project Engineer Quality

05/09/2019
- Ixelles

Job content

As a Project Engineer Quality you will support the maintainance of an appropriate and sustainable Quality Management System (QMS) in order to ensure compliance with Regulatory Authority and internal expectations.

You will be involved in:

- Product Quality System

  • Contribute in the deployment and maintenance of an effective and sustainable QMS.
  • Ensure timely implementation of all applicable global Product Quality Standard Operating Procedures
  • Ensure all relevant colleagues are appropriately trained in applicable Product Quality SOPs.
  • Supervise all processes related to GDP and GMP 

- Deviation Management

  • Investigate, together with appropriate local/global functions, deviations against Product Quality and/or Compliance requirements and track preventive/corrective actions. 

 - Local Product Dispositioning

  • Local administrative release verification in compliance with the applicable local regulations and local procedures prior to distribution/sale within the market.
  • Evaluate which returns can be taken into consideration for return to saleable stock, supervise and support local actions, in cooperation with logistics and distribution center.

- Product Complaint Handling

  • Support the process of compliant handling of product quality complaints.

- Oversight of local Repackaging and Relabeling Operations

  • Ensure assessment and approval of relabeling/repackaging contractor
  • Review documentation related to the repackaging/relabeling operation and follow-up corrections if required.
  • Obtain regulatory approval of the repackaging/relabeling activity, if required under the local regulations.
  • Inform the releasing site of the repackaging/relabeling activity.
  • Release the repackaged/relabeled product prior to distribution/sale within country.

- Development and Maintenance of Consistent Quality Culture

  • Provide ongoing education on Quality to relevant functional groups

- Local Contractor Quality Oversight

  • Oversee quality operations at contractors, which includes but is not limited to:
  • Contractor Assessment and Approval
  • Deviation Management
  • Quality System Support
  • Issue and review Metrics
Profile
  • Scientific bachelor or master certificate, (Industrial) Pharmacist is a surplus
  • Preference 1-5 years of experience working in Pharmaceutical and related industries in a Quality Operations, Manufacturing or Regulatory role
  • Previous working experience in GDP is an asset
  • Professional knowledge English and French or Dutch
  • Assess risk and make sound and effective quality decisions under pressure through analysis of data
  • Diplomatic in communication with internal and external customers
  • Show strong negotiation and effective communication skills. Is influential
  • Self-motivated individual who is comfortable with working independently
  • Able to work effectively in cross-functional teams & collaborate
  • Move from an overall picture view to details and return again, as situations develop and need change (helicopter view and ability to prioritize)
  • Computer literate
What do we offer?

We offer a full time position in an interesting industry and a competitive salary package.

Contact

For more information, contact Marieke Franken +32 16 30 95 09.