QA Validation Specialist

Job Type:
Business Transformation
Job reference:
over 2 years ago
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.
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