PRINCIPAL QA VALIDATION SPECIALIST required by CareerWise Recruitment for our Limerick based BioTech client.
The PRINCIPAL QA VALIDATION SPECIALIST will schedule, execute and review Continuing Qualification activities for large and small equipment in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.
Role of this position
- Strong Quality background and familiar with Site change controls in general.
- Assess executed change controls and deviations for impact to the Qualified state for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Schedule, execute and review Continuing Qualification activities for large and small equipment
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Collaborates with functional departments to resolve issues.
- Trains/advises less experienced Specialists.
- May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
- Manage and drives projects and prepares status reports.
- May present at both internal and external (regulatory) audits
- Stays current with industry trends, regulatory requirement updates, and communicating same to team
- May manage full time employees and/or contingent workers.
- Performs other duties assigned by Management.
- Some travel may be required.
- BS/BA in Engineering, Chemistry, or Life Sciences.
- 8+ years of related experience within the field preferred; may substitute relevant experience for education.
Please call Conor Twomey today for further information on 021 4297422 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)