Our client, a pharmaceutical company in Mayo are currently looking to recruit a Quality Assurance Manager for their site. The Quality Assurance Manager will support the the Global Engineering Quality Assurance Lead in transitioning the project to the site commercial teams.
The Quality Assurance Manager is responsible for providing quality oversight for the Global Engineering phase 2 project supporting capacity expansion of the biologic pre filled syringe drug product during the concept design phase, detailed design development, commissioning and qualification and process qualification through to regulatory facility certification. The Quality Assurance Manager will support the Global Engineering project ensuring that good engineering practice designs are incorporated throughout the project phases. Working closely with the Engineering Consultants on both conceptual and detailed design phases ensuring that the necessary GMP requirements are upheld. The role will provide support to the Global Engineering Quality Assurance Lead in achieving project goals and objectives. Provide support to the Global Engineering Quality Assurance Lead for meeting customer requirements and the necessary regulatory requirements as defined by FDA, EU and other regional Ministries of Health as relevant. The Quality Assurance Manager will represent the Quality function for assigned Global Engineering projects. The Quality Assurance Manager will support the transition of the project through the design, build, CQV phases, PPQ, registration/stability to operational readiness for GMP / PAI certification.
Key Duties And Responsibilities
- Recruit and develop a team required to support the Global engineering team to deliver the quality requirements for the assigned project. Manage team to achieve all project deliverables.
- Support the Global engineering project by ensuring that all vendors are fully compliant with internal vendor management standards/procedures. Support vendor management process by completing audits and assessing vendors against applicable regulations and guidelines.
- Provide quality/GMP evaluation of Global Engineering change controls. Support the review and approval of project documents, including but not limited to, SOPs, CQV documents and qualification documentation, protocols, and reports. Support the Global Engineering project team by participating in the Quality Risk management program supporting the internal procedures defined by ASTM E2500 standard, ICH Q9 guidance and all other applicable GMP regulations.
- Support the Global Engineering project by ensuring that all Quality System records, including but not limited to Change Controls, Non-conformances, and CAPAs. Ensure that the all investigations are completed in accordance with site procedures and records are completed in a compliant and timely manner
- Support the Global engineering team in the generation of qualification, clinical and product launch documents meeting the applicable regulatory and internal requirements
Qualifications (Minimum Requirements)
- Bachelor’s Degree in Life Science or related discipline
- Minimum of 7 years’ experience working in a GMP regulated environment, preferably in the pharmaceutical or biotechnology industries
- Demonstrated knowledge of aseptic operations
- Demonstrated knowledge of quality standards and regulations
- Valid EU work permit
Essential Skills, Experience, and Competencies
- History of building and maintaining positive relationships both internally and externally
- Proven ability to influence and motivate cross-functional teams
- Strong communicator with excellent verbal, written and presentation skills
- Can negotiate skillfully in tough situations with both internal and external groups
- Proficient in MS Office (Word, Excel, Outlook, and PowerPoint)
- Strong Technical writing ability
- Contentious and reliable worker
- Ability to understand and articulate quality requirements in a clear , consistent and
- coherent manner
For further information on this Quality Assurance Manager role in Mayo please contact Anna Carty on 086 816 8298 / firstname.lastname@example.org
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