Our partner is looking for an Vendor Quality Support to join its team. This international company is well-known for its pharmaceuticals.
Vendor Quality Support
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 intermediates, APIs, 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).
- 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.
- 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 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.
- Address CMO Connectivity Fail messages and coordinate resolution of issues internally and with appropriate vendors.
- You are fluent in English.
- You have a good knowledge in several areas of the global pharmaceutical industry.
- You have good knowledge and experienced in root cause analysis and risk management/assessment skills.
- You are able to independently analyze data and information to draw conclusions and make effective decisions.
- You can work autonomously.
- You are able to interact with and influence senior internal and external personnel.
- You are a good communicator.
- Company car
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.
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