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.
