MSI Pharma has partnered with a global biopharmaceutical company in Belgium who are looking for a Vendor Quality Lead.
This position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors engaged in GMP manufacturing activities for our clients products.
This position will also deputize for the QP during absence or travel.
Responsibilities
- Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors.
- Manage the key performance indicators (metrics) for key operational QA activities
- Ensure all Quality agreements are in place and take ownership of agreements for the vendors.
- Support the QP in relation to all batch release activity, primarily performing QA review of batch documents.
- Liaise with Vendor Team(s) and CMO's where applicable on resolution of issues relating to document errors to support release.
- To perform the Qualified Person (QP) function regarding Batch Release as defined by Directive 2001/83/EC and related legislation
- Be the QA stakeholder for Vendor Risk management.
Qualifications
- Master's Degree in a scientific subject. If Qualified Person then certification required.
- Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
- Must be able to act in most circumstances without direct supervision and handle complex / difficult situations.
- Root cause and risk management/assessment skills.
- Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
