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Validation Manager

Reference:APWX-787167
Location: Dublin
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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Validation Manager
Our client a global pharmaceutical company based in Dublin is currently recruiting for a Validation Manager to join their team on a permanent basis. The Validation Manager will manage and coordinate the activities of the Technical services team which is made up of a Validation Specialist group and a Development lab group.

Responsibilities
• Formulate and plan development studies to support new product introduction, continuous improvement and company research objectives
• Carry out validation activities as outlined in the Site Validation Policy and Site Validation Master Plan and to ensure compliance with Regulatory requirements for validation activities
• Prepare and control all validation documentation in line with relevant SOPs
• Co-ordinate the introduction of new products, processes, equipment and systems into the organisation
• Prepare and implement Installation and Operation Qualification protocols and reports to ensure the effective validation of facilities, utilities, systems and equipment
• Prepare and implement Process Validation and Performance Qualification protocols and reports and to ensure the effective validation of processes and systems
• Co-ordinate, prepare and approve cleaning verification and validation protocols and reports and procedures relating to the cleaning program
• Participate in site change control system affecting pharmaceutical products and medical devices, ensuring that all changes to validated processes, systems, facilities and utilities are effectively assessed to ensure that regulatory compliance is maintained at all times
• Assist, individually or as part of a task team, in any process problems and technical investigations as required and to be proactive in terms of contributions to process improvements and efficiencies
• Liaise with the all other departments within the organisation and with vendors to ensure project targets are achieved in a timely manner
• Responsible for overseeing the validation of computerized systems and the computerized system network
• Mentor and develop department members in line with the company Continuous Professional Development policy

Requirements
• Degree in science or engineering and postgraduate qualification in science or engineering is desirable but not essential
• Minimum 10 years post graduate experience working in a regulated environment (pharmaceutical or medical devices)
• Minimum 5 years post graduate experience working in a leadership role within the validation environment (pharmaceutical or medical devices).
• Minimum 5 years’ supervisory experience
• Experience in Six Sigma methodologies and have validation experience in the following areas: Computerised systems, Process and cleaning and new products/formulations
• Proven ability to work in cross-functional team environments, as well as independently
• Excellent written and verbal communication skills
• Strong attention to detail
• Excellent organisation skills
• Good decision making skills
• Will be proactive and flexible

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

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




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