Description
Role – QAV Engineer - Controlled Temperature UnitsType – until end of 2016
Location – Limerick, Ireland
Quanta is recruiting for a QA Validation Specialist (Controlled Temperature Units) to join one of the biggest and fastest growing start up Biopharmaceutical investments in Ireland.
You will implement policies and procedures to validate/qualify equipment, systems and processes in accordance with regulatory requirements and company manufacturing standards.
Responsibilities:
- Writing/Execution of controlled temperature unit qualifications through the following: test instrumentation setup and calibration, test instrument placement, and data analysis.
- Ensuring all aspects of validation adhere to required policies and procedures
- Generating, executing and reviewing master and completed validation protocols
- Preparing equipment for qualification studies and executes qualification and validation studies
- Analysing the results of testing and determines the acceptability of results against pre-determined criteria.
- Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements.
- Reviewing editing and approving deviation notifications, deviation investigations, and corrective actions.
- Coordinating with other departments or outside contractors/vendors to complete validation tasks.
- Training/advising less experienced Specialists and Technicians.
- Managing projects and prepares status reports.
Education and Experience:
- proven direct experience performing qualification of controlled temperature units and cold chain shipping validation studies in cGMP biopharmaceutical or aseptic liquid filling environment is required
- A third level qualification in Science, Engineering or a relevant Quality discipline
- Knowledge of cGMP requirements for biopharmaceutical and/or aseptic liquid filling processes
- Experience in Temperature mapping of Controlled Temperature Units (CTU’s) – e.g. Warehouses, Fridges, Freezers (walk-in and stand-alone), cryogenic storage units, etc.
- Hands-on experience of performing temperature mapping and managing service providers