Our client a pharmaceutical company in Mayo is looking to hire a Quality Assurance Specialist for their site.
A QA Specialist will hold responsibility for QA activities in support of all aspects of commercial, clinical and development activities at the site. The specialist will assist Senior manager in the management of key quality system elements including:
- Deviation management
- Change Control Program,
- Inspection Management: (Coordinate site GMP inspections; Internal site preparation; pre-audit MOH requests; Response/report compilation & issuance; Post audit commitment management);
- Quality metrics & monthly quality system & Senior Management review meetings; (Meeting preparation and coordination of post meeting commitments
- Manage regulatory standard/guidance revision assessments:
- Coordinate the site quality plan and ensure plan execution:
- Manage compliance initiatives program:
- Management of site quality risk management program: (Management of the site QRM improvement plan. Attend risk assessment meetings)
- Work with the Snr Manager on the delivery of the company quality plan and global regulatory requirements for the site
- Assess quality implications of new regulatory guidance and implement necessary changes
- Manage quality requirements for process changes & new product introductions as deemed necessary
- Ensure effective recording, analysis and reporting of quality KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement.
- Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program.
- Represent the company in Ministries of Health inspections as required
- Provide quality input as required, providing information on day to day activities as a member of the site quality team.
- Work with business unit representative and supporting functions to ensure site and global quality metrics are achieved and exceeded each month through the implementation of department process improvements and working with key site vendors to ensure high quality standards are implemented.
- Co-ordinate quality management system for area of responsibility and site overview
- CORAL: Review and approval of assigned documentation as deemed necessary and the process quality agreements.
- Coordinate site quality monthly meetings for assessment of quality system performance
- Compile quality metrics for business units and support functions
- Compile data and coordinate meeting requirements for the bi-annual senior management review meetings as per regulatory requirements
- Coordinate the review of revisions to regulatory standards/guidance
- Assist in the preparation and management of site MOH and customer inspections
- Management of vendor audit program
- Review and approval of Trackwise records and associated documentation
- Complete assigned internal and external audits
- Management of completion of interventions for media run schedule for the business units
- Coordination of site residual monitoring program.
- Attend all routine meetings as required or arrange an appropriate deputy. For example: Site Project meetings/EH&S Meetings, Tier Boards/OPEX meetings as assigned.
- Ability to independently represent the quality function at project meetings and make sound decisions in support of project needs ensuring quality needs are understood and implemented
- Third level Science qualification
- Proven track record in a quality discipline in the Pharma/Medical Device environment
For further information on this Quality Assurance Specialist role in Mayo please contact Clara Burke on 086 8168273 / firstname.lastname@example.org
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