Vendor Quality Support

  • Location: Braine-l'Alleud
  • Type: Contracting
  • Job #19133

Vendor Quality Support 

Brabant Wallon – Contracting 

Our partner is looking for an Vendor Quality Support to join its team. This international company is well-known for its pharmaceuticals. 

What are your responsibilities?

In this transversal matrix role you will provide Quality expertise and support to a group of Vendor Quality Lead professionals who manage and oversee operational quality management of externalized manufacturing activities for bulk and finished drug products.

Here are your main tasks : 

  • Review annual stability protocol and reports. Communicate any trends to the Vendor Quality Lead (VQL).
  • Perform review of CMO PQR within agreed timeframe, complete PQR Assessment and discuss outcome with VQL.
  • Participate to Quality Agreements (QAA) periodic reviews and draft QAA according to available templates.
  • Perform stakeholder review of various change controls, support change control preparation, keeping change control trackers up to date accordingly. 
  • In specific cases, review Validation and Technical Transfer protocols and reports liaising with VQL.
  • Review Master Batch records changes linked to change controls or to support initiation.
  • Investigations/deviations/ out-of-specifications. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders to allow and perform assessment.
  • If needed work with the Vendor Quality Lead, the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinate vendor quality related investigations.
  • Support Audits preparation at the company or at the vendors, when relevant act as SPOC in case of the company audits and follow-up CAPAs in Trackwise.
  • Support Risk based evaluation of the vendors in collaboration with VQLs.
  • Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the assigned products and activities at the vendors. This can include participation to various QA improvement projects.
  • Address CMO Connectivity Fail messages and coordinate resolution of issues internally and with appropriate vendors. Ensure regular update of relevant guidance.
  • Act as substitute for other Quality Vendor Support/Vendor Quality Leadsin times of absenteeism (e.g. Vacation, illness, etc.)
  • Work in accordance with the company HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
  • Quality Complaints: Perform trend, recurrence analysis with the Central Complaint Unit, escalating issues to VQL.
  • Be a contact person for the follow-up with vendors for the manufacturing investigation part. 

Who are you?

  • You are fluent in English 
  • You have 5-10 years professional experience & knowledge in a Quality role in the pharmaceutical industry preferably in the GMP operations environment
  • You can work autonomously, you have a good communication, you have an excellent interpersonal, verbal and written communication .. 

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Marie ROSSENFOSSE: [email protected] 

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!