Vendor Quality Support
Brabant Wallon – contracting
Our partner is looking for a Vendor Quality Support to reinforce its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines
What are your responsibilities?
- 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
- 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 our partner or at the vendors
- 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.
- Address CMO Connectivity Fail messages and coordinate resolution of issues internally and with appropriate vendors. Ensure regular update of relevant guidance.
- Quality Complaints: Perform trend, recurrence analysis with the Central Complaint Unit, escalating issues to VQL.
Who are you?
- You hold a bachelor’s degree (or master’s degree) in a Scientific orientation
- You have 5 to 10 years professional experience & knowledge in a Quality role in the pharmaceutical industry preferably in the GMP operations environment
- Hands-on field experience in failure investigations, root cause analysis, deviation review
- Solid knowledge about European Good Manufacturing Practices (Eudralex Vol. 4)
- You are fluent in English
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 Sophie Rolis : [email protected]