Sector: Life Sciences
Consultant: Life Sciences Team
Salary: £43800 - £52500
Job Status: Permanent / Full Time
My client and I are looking for a Quality and Validation Manager (CSV) to be based at the Dublin office.
- Maintaining and managing quality systems and validation systems, including developing and establishing quality procedures, standards and specifications
- Providing strategic direction to related governance functions (e.g. Risk Management, IT, HR, Legal, Compliance) as well as senior and middle managers throughout the organization as required
- Leading quality and continuous improvement programs, developing and implementing the next generation of quality programs and tools
- Working cross-functionally with all relevant teams, vendors, and customers to determine gaps between current performance and the optimal organization performance (including internal processes and external certifications such as ISO 9001, PS 9000, ISO 27001 and others as required)
- Working with the Premedia Quality Manager on cross functional sections of the system of the QMS and maintaining procedural alignment on the dual system
- Managing and developing the CAPA, Customer complaints and Change control system
- Managing customer complaints and communicating directly with customers on quality related matters
- Managing internal and external audits, working closely with the internal audit team
- Training staff in all areas of quality, GMP and appropriate regulations
- Overseeing the validation process for new system installations.
- Managing validation team including local and remote team members – providing mentoring, performance management including goals and objectives and regular review meetings
- Ensuring the continued validated state of the GLAMS product and ensuring compliance to 21 CFR Part 11, Annex 11 and other appropriate regulations e.g. those related to data integrity and security
Qualifications, Skills and Experience Required
- Qualification in Quality, Computer Systems or other relevant discipline
- Previous experience of developing or implementing (ideally both) a Quality Management system to ISO 9000/ISO 27001 or similar standards
- Must have demonstrated experience in developing and deploying process improvements and best practices across organizational functions with a clear focus on measurable results.
- Experience of managing internal and external auditing
- Minimum 2-3 years’ experience within pharmaceutical industry in a related role
- Minimum 2 -3 years’ experience in Validating software system to GAMP 5 guidelines