Biopharmaceutical Company based in Limerick is seeking a candidate who is looking to work within a challenging yet rewarding Biotech start up environment. The successful candidate will serve as QA Validation Specialist.
The company are building the largest biotechnology manufacturing facility in Ireland at a rapid pace. The company has a strong culture of innovation and R&D.
A brand new role to the site the progression opportunity is like no other. If you have proven background in Validation and QA this is the role for you. They will at both junior and mid-level candidates.
Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures
Essential Duties and Responsibilities include, but are not limited to, the following:
- 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
- Analyzes 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
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Manages projects and prepares status reports.
- May be required to oversee contingent workers.
Education and Experience:
- BS/BA in Engineering, Chemistry, or Life Sciences with 1- 3 years of related experience within the field preferred; may substitute relevant experience for education.
To hear more about the company and role please contact me for immediate consideration please apply with an up to date CV.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales