Excellent new opportunity for an ASSOCIATE SPECIALIST QA VALIDATION with c1-2 years relevant experience with a top employer in LIMERICK for an initial 12-month contract.
The successful candidate will be involved with implementing policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
Please contact 091 373 938 /for further information on this new role.
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 Regeneron SOPs.
Manages projects and prepares status reports.
1 - 2 years' relevant experience in a medical device, pharma or bio pharma company.
Degree in a Scientific/Engineering discipline or relevant area. Strong experience may be substituted for educational requirements.
Ability to demonstrate good communication skills.
Please call Michelle Galvin today for further information on 091 373 938 or email:
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.