Our client, a pharmaceutical company in Mayo are currently looking to recruit a Quality Assurance Specialist for their site.
The Quality Assurance Specialist is responsible for providing quality oversight for Eye care projects and supporting projects through design phase, detailed design development, commissioning and qualification and process qualification through to regulatory certification where required. The Quality Assurance Specialist will ensure that good engineering practice designs are incorporated throughout the project phases.
Key Duties and Responsibilities
- Support projects 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 applicable 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 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.
- Participate extensively as a key company representative during Regulatory inspections pertaining to Multidose Products and Processes.
- Ensuring that all Quality System records are managed, 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 new product introductions, product projects in the generation of qualification, clinical and product launch documents meeting the applicable regulatory and internal requirements.
- Bachelor’s Degree in Life Science or related discipline
- Minimum of 7 years’ experience working in a GMP regulated environment.
- Experience working with Pharmaceutical and Medical Device products
- Demonstrated knowledge of Quality Systems, Validation requirements, quality standards and regulations
- Experience working in an aseptic environment – knowledge of aseptic practices
- Demonstrated ability to successfully manage or participate as a key member in projects
- 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 skilfully 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
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