A Sr QA Validation Specialist is required by CareerWise Recruitment for our Limerick based client.
Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.
Role of this position
- Responsible for all aspects of the Cleaning Validation programs onsite for a large-scale Biopharmaceutical Drug Substance production facility.
- 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.
- 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.
- BS/BA in Engineering, Chemistry, or Life Sciences.
- 5+ years of related experience within the field of Cleaning Validation in Biopharmaceutical, Aseptic Fill/Finish or API manufacturing.
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
Please call Lisa Casserly today for further information on 091-339136 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)