- Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:
- Qualification of premises, equipment and utilities.
- Computer system qualification.
- Laboratory equipment validation.
- Process validation.
- Cleaning validation.
- Prepare and maintain policies and SOPs associated with validation.
- Ensure that all change controls are assessed for impact on validation.
- Review and Approval of validation master plans.
- The QA Validation will execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities.
- Participate in cross-functional project teams as the validation representative.
- Participate in other projects as directed by the Quality Systems & Compliance Manager.
- Third level degree in a scientific discipline
- 5 years’ experience working within quality in the pharmaceutical industry
Please call TJ Vinod on +353 21 235 9144 or email firstname.lastname@example.org for a confidential discussion.
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