Vendor Quality Lead – QP
Contracting – Walloon Brabant
Our partner is currently looking for a Vendor Quality Lead to join its team. This international company is well-known for its pharmaceuticals.
What are your responsibilities?
In this position, you will support the Qualified Person (QP) in relation to all batch release activity for Global products produced by third parties, primarily performing QA review of batch documents, issue of batch certificates, and transactional release activities.
Vendor Quality Lead (VQL) related accountabilities:
- Be the central QA point of contact for the organization for investigations/deviations/ out of-specifications/ audit observations associated with the assigned vendors.
- Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders allow assessment.
- Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance.
- Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product CMC Quality Leads and the vendors.
- When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the internal Stability Program
- Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the internal Controlled Documents System.
- Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings.
- Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors.
- Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way.
- Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors.
- Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors.
Qualified Person related accountabilities:
- Support the QP in relation to all batch release activity, primarily performing QA review of batch documents.
- Issue batch certificates for product release and distribution
- Perform in SAP the transactional product release and maintenance of batch release register
- Liaise with Vendor Team(s) and CMO’s where applicable on resolution of issues relating to document errors to support release.
- Act as QA contact (in conjunction with site QP) and deputize on behalf of QP where appropriate for product related quality issues and associated communications.
- Act as a contact with other departments and Affiliates to support the drug product /Finished goods release process and supply of post release documents.
- Maintain and report Metrics relating to batch release activities.
- Support Global Regulatory Affairs and CMC Quality Leads for submission document requests
- Coordinate legalization/notarization of documents as needed
Who are you?
- Eligibility as a Qualified Person in EU
- Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
- Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
- Must be able to act in most circumstances without direct supervision and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
- Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
- Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations.
Our offer?
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.