Qualified Person – Dublin – 11 Month Contract
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Qualified Person.
Based in Dublin, the successful candidate will be responsible for the disposition of material, including QP certification of product and work closely with colleagues in the Quality organisation, providing oversight of contact manufacturers, testing facilities and for leading, monitoring and supporting the quality performance of appropriate quality systems according GMP.
The QP will be responsible for ensuring that medicinal products have been manufactured and tested in accordance with GMP and the products’ Marketing Authorisations.
The successful candidate may be responsible for, but is not limited to:
- Working with existing disposition teams in the US (Lexington, MA) and EU (Dublin, Ireland) and other sites to establish new products within the Client’s model for disposition of externally manufactured biologics (bulk drug substance, filled un-labelled vials, finished drug product).
- Ensuring MA/BLA compliance (manufacturing and testing) of externally manufactured biologics.
- Participating in Continuous Improvement and Visual Management standard methodologies.
- Performing batch disposition.
- Maintenance of the QP batch register.
- SOP / Specification / Technical Protocols/ Reports Review / Approval.
- Leading investigations.
- Reviewing and approving batch records, deviations and change controls.
- Designing, implementing and improving quality metrics and quality systems.
- Leading meetings and audits.
- Facilitating process improvement projects.
- Implementing, reviewing and maintaining Quality Agreements, as required.
- Assisting in meetings with external parties and representing the Client in a professional manner.
- Eligible to fulfill the role of QP as per EU GMP requirements.
- Authorised to release or reject batches of commercial material / product.
- The QP should ensure that the appropriate resources to ensure systems and communications are in place and in operation.
- Access to senior management.
- Access to any documentation required to fulfill responsibilities.
- Qualify or disqualify CMOs, distributors and contract test laboratories as required.
- Kept informed of changes in the organisation that could affect the MIA by senior management.
- Kept informed of the internal and external audit schedule and reports covered in the MIA.
- Approve Quality Agreements.
To be considered for this position please apply below.