Description
Global healthcare company based in North dublin is seeking a QA Manager.Major Duties & 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.
* Travel to off-site locations to ensure and aid the quality infrastructure and appropriate quality systems for alignment to QA Third Party Manufacturing Quality or Technical Agreements.
* 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.
* Ensure the appropriate GMP requirements are met for the validation of the product, process, equipment and facility. Be the final approver of these documents.
* 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.
* Complete management reviews with assigned TPM's that identify and address quality, operational, and organizational issues.
* Support TPM Quality Heads in providing quality and compliance support/advice for finished dosage form product manufacturing, packaging, and labelling to the TPM's
* Provide support for quality audits, initial site approvals.
* Provide technical expertise and hands-on service, utilization of systems and additional The companies resources to support quality and compliance related activities that are deficient at the TPM.
Supervisory/Management Responsibilities:
* Responsible for assigned Quality Specialists.
* Frequent contact with the companies personnel at many levels, Divisions and Affiliates
Educational Requirement:
A 3rd level degree in a relevant Quality or technical/scientific discipline.
Experience Required:
- Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with 8+ years in QA, Operations, or Technical Support in a pharmaceutical setting.
- Manufacturing related experience in some of the following areas: sterile, liquid, solids or API's.
- Audit experience of suppliers in pharmaceutical industry
To hear more about the company and role please contact me Anna Mooney or apply below with an up to date CV.