Description
My Client a global Healthcare company based in Dublin is seeking a QA Manager.The sucessful candidates function within the company will be to manage the quality related activities at a number of Third Party Manufacturer's (TPM's) within the EU Region on behalf of the company, to ensure safe, efficacious and quality product can be supplied in accordance to regulatory and business requirements.
MAJOR DUTIES AND RESPONSIBILITIES:
-Manage TPM's as assigned from a Quality perspective.
-Approve the Quality/Technical Agreements to align with the legal contracts.
-Implement and maintain a program/project management process to support quality and compliance initiatives at TPMs.
-Participate on QA cross-functional teams to support TPMs, as necessary.
-Participate in long-range planning efforts for capacity (people, systems).
-Co-ordinate the check of regulatory filings by creating RIA and approving change requests generated for external manufacturing of drug products and API's. -Support the management of critical exception documents and CAPA. May act as the primary quality review and decisions maker for relevant TPM exception documents for impact on product quality, safety, efficacy and impact to the regulatory filing.
-Coordinate and approval activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
-Prepare, review and approve Annual Product Quality Reports to ensure accuracy, completeness, timeliness, and those trends are identified and addressed in an appropriate manner.
-Support TPM Quality Heads in providing quality and compliance support/advice for finished dosage form product manufacturing, packaging, and labelling to the TPM's.
-Support the pre-approval inspection readiness as related to the TPM to ensure regulatory approvals are obtained, with no delays to market entries.
SUPERVISORY OR MANAGERIAL RESPONSIBILITY
-Responsible for assigned Quality Specialists .
-Frequent contact with Abbott personnel at many levels, Divisions and Affiliates
-Close contact with TPM personnel at all levels
EDUCATION REQUIRED:
3 rd level degree in a relevant Quality or technical/scientific discipline.
EXPERIENCE:
-Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with 8+ years in QA, Operations, or Technical Support in a pharmaceutical setting.
-Experience in some of the following areas: sterile, liquid, solids or API's. -Audit experience of suppliers in pharmaceutical industry
If you are interested in this great opportunity please contact me Anna Mooney or apply below with an up to date CV. Sthree UK is acting as an Employment Agency in relation to this vacancy.