Our client offers a unique, world-class opportunity for interested candidates. They have been consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Our client is fully committed to bringing their award-winning approach to their subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.
Summary: Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
- Aids in investigations and troubleshooting as part of a multi-functional team to determine 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
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Reviews, edits and approves reports, such as, Automation performance evaluation reports, and other reports or documentation submitted to the department
- Trains/advises less experienced Specialists and Technicians.
- Assesses quality system documentation for completeness and accuracy, and dispositions documentation within the client SOPs.
- Manages projects and prepares status reports.
Experience And Required Skills :
* BS/BA in Engineering, Chemistry, or Life Sciences with years of related experience within the field preferred; may substitute relevant experience for education.
This is an opportunity to join our Clients selected team that is already leading the way in the Pharmaceutical/Biotech industry.