This company's award-winning approach is committed to bring on an experienced QA Specialist to
validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support. You will also follow and implement company manufacturing standards policies and procedures
This position will have influence with the business so will require someone that is able to work well independently while maintaining strong working relationships across all areas of the company.
Essential Duties and Responsibilities include, but are not limited to, the following:
*Responsible for all aspects of the Cleaning Validation programs onsite for a large scale Bio-pharmaceutical Drug Substance production facility.
*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.
*Analyse 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.
*Collaborates with functional departments to resolve issues.
*Trains/advises less experienced Specialists.
*May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
*Manage and drives projects and prepares status reports.
*May present at both internal and external (regulatory) audits
*Stays current with industry trends, regulatory requirement updates, and communicating same to team
*May manage full time employees and/or contingent workers.
*Performs other duties assigned by Management.
Education and Experience:
*BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the field of Cleaning Validation in Bio-pharmaceutical, Aseptic Fill/Finish or API manufacturing;
Please apply directly or contact Stefan Moro for more details on 01 6455217 or stefan.moro@ manpower.ie