Situated in Co. Kildare, my client 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. My client has been an established leader in the supply of medicines for over twenty years and is currently expanding its product portfolio.
The Quality Function is seeking a experienced Quality Assurance Lead / Qualified Person to support this 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.
This is an exciting career opportunity to operate in a dynamic team environment, meeting business objectives through effective leadership (coach, mentor and lead) - developing and supporting high performing teams in delivering solutions.
We would love to hear from candidates who have the following previous experience:
o Contributes as a QA leader as part of a cross functional team, and as a member of the QO leadership team.
o Ensuring a constant state of compliance and audit readiness is maintained in line with current regulations, Quality Standards and business needs
o Decision making authority with respect to product quality, safety and efficacy in consultation with relevant stakeholders
o Responsible for batch disposition in line with QP Annex 16 requirements.
o Quality oversight on Change Controls and Investigations (manufacturing, complaints, laboratory).
o Management and oversight of Product Stability performance.
o Annual Product Record Review approvals.
o Quality oversight for Validation (process, equipment, computer systems).
o Quality oversight for raw materials, packaging components, in-process product and supplier qualification.
o QA support for the introduction of new, innovative products
o Providing QA technical direction and guidance to achieve overall business objectives.
o Ensuring the QA function delivers efficient and effective business processes to support lean operations.
o People reporting responsibilities, which includes selection and recruitment of colleagues. He/she will support a team of c. 4 -5 people.
o Responsible for area budget preparation and management in conjunction with the Quality Operations Lead.
Applicants will have:
o Third level Qualification Degree or higher in Science or a related discipline Experience in both QA and QC is desirable.
o Eligibility for Qualified Person status (essential)
o Five years’ experience in a Pharmaceutical Management position.
o Ability to interact in a corporate environment, with proven leadership qualities.
o Ability to represent the company in external forums, e.g., in interaction with regulatory agencies.