QA Validation Specialist - Cleaning
A QA Validation Specialist is required to join a leading biotechnology manufacturing company based in Limerick. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.
This role will be responsible for the development and execution of cleaning validation of process equipment used in the direct manufacture of biopharmaceutical drug substances. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry.
Key Responsibilities
- Generates, executes, reviews, approves, master and completed cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Prepares equipment for qualification studies, executes qualification and validation studies according to approved protocols and SOPs.
- 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.
- Initiates, reviews, edits and approves change control and SOPs
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Day to day oversight of cleaning validation contract specialists where required.
- Assesses quality system documentation for completeness and accuracy, and dispositions documentation per Regeneron SOPs.
- Manages projects and prepares status reports.
Education/Experience
- Requires a BEng/BSc in Engineering, Chemistry, or Life Sciences with 2+ years of related experience within the field; will substitute relevant experience for education. Qualification/validation experience required.
- Ability to work on own initiative, without direct supervision from management.
- Team player with an ability to work well across various departments on site as well as business partners.
- Excellent written, presentation, communication and investigation skills.
- Deadline focused individual.
Interested? Contact Jack on 01-6455250, or Click Apply below!
