An exciting role for a Product QA Manager to join the team in Liffey Valley for a 6 month contract role.
PRIMARY FUNCTION: The Senior Quality and Product Specialist is responsible for providing QA general support for assigned TPM's and quality systems to ensure that safe, efficacious and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.MAJOR DUTIES AND RESPONSIBILITIES: Manage TPM's as assigned from a Quality perspective.Provide support of global quality and compliance strategy for assigned commercialized products with global/multiregional scope.Serve as product quality and compliance resource during planning and execution of major changes for assigned commercialized global products.Co-ordinate the change control program for changes impacting products manufactured at assigned TPMs.Prepare Quality/Technical Agreements to align with the legal contracts.Support 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 decision 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 approve 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 that trends are identified and addressed in an appropriate manner.Support the TPM QA management and approval of exceptions documents and CAPA's elevated by TPM's and ensure that where appropriate senior Quality management are notified.For assigned TPMs, 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.Support the pre-approval inspection readiness at TPM to ensure regulatory approvals are obtained, with no delays to market entries.Minimum Requirements EDUCATION: 3rd level degree in a relevant Quality or technical/scientific discipline.EXPERIENCE: Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with 5-8 years in QA, Operations, or Technical Support in a pharmaceutical setting.Manufacturing related experience in some of the following areas: sterile, liquid, solids or APIs.Audit experience of suppliers in the pharmaceutical industry.Troubleshooting and issues resolution skills.Project management expertise.Perceptual and analytical problem solving related to removal of obstacles, setting priorities, people, resources and facilities involvement.Ability to communicate effectively, both orally and in writing to both internal and external audiences.Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives.Ability to use Quality Risk Management tools.
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