Description
Global Pharmaceutical are seeking a QA Manager to join their quality team, offering support to the QA technical team for manufacturing locations the successful candidatemanager will manage TPM's as assigned from a quality perspective.Day to Day:
*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.
*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.
Required:
*Responsible for assigned Quality Specialists .
*Frequent contact with personnel at many levels, divisions and affiliates
*Close contact with TPM personnel at all levels
*Continuous contact with Quality Director and appropriate workstream teams.
*3rd level degree in a relevant Quality or technical/scientific discipline.
*Proficiency in speaking, comprehending, reading and writing English is required / preferred.
*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
If you are interested in this great opportunity please apply below with and up to date CV and I contact suitable candidates promptly with more information. This is an urgent requirement, interviews will take place as soon as next week.