Pfizer Quality Lead in Kildare, Newbridge, Ireland
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 highly complex processes. The site has been an established leader in the supply of medicines for over twenty years and is currently expanding its portfolio.
The Quality Function is looking to hire a number of experienced Quality Leads / Qualified Persons to support this additional activity on-site. The successful candidates will manage all Quality Assurance Activities associated with a Business Unit or a specific Process Team for a defined suite of Products.
We would love to hear from candidates who have the following previous experience:
Contribute 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
Decisions 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.
Quality oversight on 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 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.
One of the roles will have people reporting responsibilities which will also include 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 Site Quality Operations Leader.
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 (essential)
Five years' experience in a Pharmaceutical Management position.
Ability to interact in a corporate environment and proven leadership qualities.
Ability to represent the company in external forums, e.g., in interaction with regulatory agencies.
Closing date for applications is Friday 16th March.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.