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Head of Validation


  Warsaw,   75K

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  Engineering    Permanent

Vacancy Details

My client, a leading European Biologics  company are looking for a Head of Validation. It’s a great opportunity to join a business that recently undergone huge investment and moving into commercialisation for a number of new products.

Title: Head of Validation

Salary: Competitive

 

Responsibilities:

Key Responsibilities

  • Review and approval of Validation Site Masterplan(s)
  • Mapping and planning QA validation activities and assessing the resources and timelines that are needed to complete activities
  • Leading Quality Assurance of Qualification and Validation of Facilities, Equipment, Utilities, Computerized Systems and Process/Cleaning validation activities
  • Review and Approval of validation protocols and reports, as required
  • Performing and approving Risk and/or Impact assessments with respect to validation and qualification activities
  • Review and QA Approval of Quality event records related to validation and qualification activities such as Deviation, CAPA, Change Controls etc.
  • Generation, review and approval of Quality Management System SOPs related to Validation, as required
  • Maintaining a high level of compliance focus in meeting Health Authority requirements and expectations (GIF, FDA etc.)
  • Validation strategy approach, decision making and regulatory expectation of decisions
  • Conducting risk-based evaluations, justifications and adequately reviewing and sponsoring the generation of QA systems derived documentation
  • Successful planning, execution and delivery of validation projects and associated documentation packages via engagement with business units (e.g. IT, Automation, Engineering, Quality Control), contractors and vendors

Looking but this isn’t the right position for you?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to or call +49 6995179969 for a confidential discussion about potential opportunities.

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Joe.Lane

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