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 / email@example.com for further information on this new role.
Role of this position
- 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: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)