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VALIDATION MANAGER - MEDICAL DEVICE

 

Validation Manager to join the  Quality Department of this excellent organisation

The successful candidate for this role will:

·          Manage all of the Validation engineering functions at the site

·          Lead, integrate & project manage Validation tasks from initial concept through to successful completion and delivery.

·    

      Continue to seek, support & drive cost saving initiatives where Validation is involved or accountable for the functions

·          Develop the plans and resource requirements including skill mix to deliver the Validation objectives whilst supporting development needs and operational efficiency

·          Co-ordinate Validation activities with all stakeholders through commercialization

·          Implement Validation processes and site master Validation planning

·          Close co-ordinations with other functions such as engineering, quality assurance, safety, operations and Production

·          Develop themselves as an expert in their area of responsibility for a long-term support of the operation.

·          Prepare monthly reports with emphasis on timing and cost estimation in the area of responsibility.

·          Follow cGMP guidelines, safety procedures, and SOPs at all times.

·          Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities.

·          Be accountable that Validation activity is conducted in compliance with US and EU legislation; as well as, Company Standards and Guidelines to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.

·          Provide processes for Validation activities in compliance with global regulations, GBSC procedures and EHS requirements.

·          Participate in the design of systems and equipment to ensure that they comply with GMP requirements.

·          Review and approve documents prepared by the Validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).

·          Execute qualification protocols as required.

·          Prioritize qualification activities in line with the project schedules and plant priorities.

·          Participate in cross-functional teams as required and Work in other areas as needed.

 

·    Bachelors Degree from an accredited college or university, preferably in an Engineering discipline

·    In-depth knowledge of Validation processes, Medical Product Manufacturing, especially high automated processes or Aseptic operations.

·    Experience in FDA or IMB regulated manufacturing and proven management experience in a Quality organization

·    Strong project management skills and Competent Validation knowledge with good organizational/administrative skills

·     Effective communication and presentation skills in one-on-one and group situations.

·          High proficiency in using Microsoft Word, Excel, PowerPoint and MS Project

·          Manufacturing Execution System design and implementation

·          Ability to understand manufacturing processes, and to identify improvements.

·          Excellent skills to prepare written policies, procedures and reports.

·          Ability to handle various responsibilities simultaneously.

·          Able to work rotating shifts and extended hours as required.

·          Required to wear clean room gowning and appropriate PPE.

·          Self-directed and self-motivated, Customer focus, excellent attention to detail

·          Results and performance driven, Adaptable and flexible

 

For further information on this and other similar jobs please contact Nicola Reid on 01- 256 8705 or email her at Nicola.reid@jobs.hudson.com

Hudson is a leading provider of permanent recruitment, contract professionals and talent management solutions worldwide.   Please note you will receive an automated response advising you that we have received your CV.

 

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