The successful candidates will manage all Quality Assurance Activities associated with a Business Unit
Quality Manager Lead/ QP- Leinster-Pharmaceuticals
Are you a quality manager/lead who is QP qualified/ eligible and looking for the opportunity to get on the QP license?
My client is seeking an experienced Quality Management Lead/ Qualified Person to support additional activity on-site. The successful candidates will manage all Quality Assurance Activities associated with a Business Unit for a defined suite of Products, also fulfilling a Leadership role within the Quality Team.
- Contributes as a QA leader as part of a cross functional team, and as a member of the QO leadership team.
- Ensuring a constant state of compliance and audit readiness is maintained in line with current regulations, Quality Standards and business needs
- Decision making authority with respect to product quality, safety and efficacy in consultation with relevant stakeholders
- Responsible for batch disposition in line with QP Annex 16 requirements
- Quality oversight on Change Controls and Investigations (manufacturing, complaints, laboratory).
- Management and oversight of Product Stability performance.
- Annual Product Record Review approvals.
- Quality oversight for Validation (process, equipment, computer systems).
- Quality oversight for raw materials, packaging components, in-process product and supplier qualification.
- QA support for the introduction of new, innovative products
- Providing QA technical direction and guidance to achieve overall business objectives.
- Ensuring the QA function delivers efficient and effective business processes to support lean operations.
- People reporting responsibilities, which includes selection and recruitment of colleagues. He/she will support a team of c. 4 -5 people.
- Responsible for area budget preparation and management in conjunction with the Quality Operations Lead.
Education and experience:
- Third level Qualification Degree or higher in Science or a related discipline
- Experience in both QA and QC is desirable.
- Eligibility for Qualified Person status (essential)
- Five years' experience in a Pharmaceutical Management/ leadership position.
- Ability to interact in a corporate environment, with proven leadership qualities.
- Ability to represent the company in external forums, e.g., in interaction with regulatory agencies.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.