Excellent opportunity to join a state of the art Bulk Biologics facility in Limerick
I am currently working with a leading biotechnology company, who are based in Limerick, that invents life-transforming medicines for people with serious diseases. This company are going through huge expansion at the moment and are on the lookout for a Principal QA Validation Specialist (CSV) to join their team on a Permanent basis.
This individual will be part of a team who Validate/qualify site computerised systems, and processes in accordance with regulatory requirements.
This company will give you brilliant exposure to a fast paced, full on facility where the growth potential and promotional opportunities are well within your grasp. This is an excellent opportunity for anyone who loves to be kept busy and are highly career focused.
- Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyses the results of testing and determines the acceptability of results against pre-determined criteria.
- 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.
Experience And Required Skills :
- BS/BA in Engineering, Chemistry, or Life Sciences
- 8+ years of related experience within the field preferred
- Experience with qualification of IT Enterprise systems or MES PAS-X would be an advantage.
- Experience of implementing systems in accordance with 21CFR Part 11 regulations i.e. Electronic Sigs & Electronic Records which also leads on to data Integrity & Audit Trail review.
- Project management experience will be an advantage
If you would like to hear more about this opportunity then get in touch today on 021 2300 300 or by email email@example.com
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