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Details

Senior GMP Inspector


Reference:APMQ-274061 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Senior GMP Inspector
Our client, a large regulatory body, are currently recruiting for a Senior GMP Inspector to join their team. As Senior GMP Inspector, you will carry out GMP inspections and scientific evaluation across the full range of manufacturing and testing sites in accordance with the requirements of GMP.

Responsibilities
• Carry out GMP inspections and scientific evaluation across the full range of sites in accordance with the requirements of EU GMP
• Supporting the GMP Manager in the management and ongoing development of the GMP inspection team
• Providing leadership, support and direction to the GMP inspection team
• Ensure strategic and operational goals set for GMP inspection team are achieved
• Support the development and maintenance of integrating processes across the inspection teams to ensure the strategic and operational goals of the Compliance department are achieved
• Managing and supervising the GMP inspection team
• Working with the GMP Manager to plan and organise work tasks to ensure efficient delivery of work
• Providing support to all staff in the GMP inspection team
• Prepare, organise and carry out inspections in accordance with procedures

Requirements
• 3rd level degree in biotechnology, pharmacy or other relevant life science discipline
• Minimum of 4 years relevant work experience working in a facility that manufactures biotech and/or sterile medicinal products in any of the following: quality assurance, compliance, quality control, production, technical services or validation, and/or,conducting GMP inspections at manufacturers of biotechnology or sterile medicinal products
• Knowledge of validation requirements including facility and equipment qualification and process, computer and assay validation
• Inspection / audit experience
• Evidence of excellent communication and report writing skills
• Evidence of effective decision making and planning and organisation skills
• Relevant experience in people management
• A valid full driver’s licence and vehicle
Desirable Experience
• A relevant post graduate qualification
• Worked as a Qualified Person
• Experience in the manufacture of medical devices
• Excellent interpersonal skills
• A strong customer service focus and be adaptable to organisational needs
• Be a self-starter and have the flexibility to adapt to changing priorities and take responsibility to ensure that a successful outcome is achieved
• Availability to travel for national and international inspections is a requirement in this role

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252