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
- 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
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