Cpl in partnership with our client Pfizer are looking to hire a QA Lead-Senior Manager for their site in Newbridge Co. Kildare
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Through your expertise and extensive knowledge, you will be able to foster a culture that promotes quality and compliance and thrives on doing better for patients and healthcare - your contributions will directly impact patients.
Situated in Co. Kildare, Pfizer Newbridge is an integral part of the global solid oral dose network; manufacturing tablets and capsules for world markets using leading edge and highly complex manufacturing processes.
The Newbridge site has been an established leader in the supply of medicines for over twenty five years and is currently expanding its product portfolio. The Quality Function is seeking an experienced Quality Assurance Lead / Qualified Person to support this additional activity on-site.
The successful candidate will manage all Quality Assurance Activities associated with a Business Unit for a defined suite of Products, also fulfilling an influencing role within the Quality Team. This is an exciting career opportunity to operate in a dynamic team environment, meeting business objectives through effective direction (coach, mentor and lead) - developing and supporting high performing teams in delivering solutions.
Expectations / Responsibilities of the Role
- Contributes as a QA leader as part of a cross functional team, and as 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
- 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
Applicants will have:
- 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 (desirable)
- Experience in a Pharmaceutical Management 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.
Work Location Assignment: On Premise