- Reference: GY43739
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
- Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
- Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
- Analyzes 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 control and SOPs.
- Collaborates with functional departments to resolve issues.
- May review, edit and approve HEPA certification reports, Automation performance evaluation reports, Cleaning validation reports, Steam Sterilisation qualification reports, Utility Qualification reports, CSV reports and other reports or documentation submitted to the department.
- May trains/advise less experienced Specialists and Technicians.May supervise, provide direction and assign work to Validations Specialists and/or Contract personnel to meet goals and deadlines.
- Assesses quality system documentation for completeness and accuracy, and dispositions documentation within SOPs.
- Manages projects and prepares status reports.
Skills, Experience and Qualifications:
- BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; will substitute relevant experience for education.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com
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