Lab CSV
- NI & Ireland
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Laboratory Validation Specialist required for a world Leading bio tech organization who are at a Peak phase in establishing an innovative and industry leading manufacturing facility in Dublin Ireland.
Working in their state of the art Laboratories, the Lab Systems Engineer will be responsible for Validating varied systems and bench top analytically equipment
Key Duties are as follows:
- Evaluate systems/equipment in accordance with cGMPs, Part 11, and other regulatory requirements.
- Input and define User Requirement specifications
- Working closely with user groups to evaluate, develop, implement and maintain laboratory equipment and systems.
- To work with laboratory personnel to improve processes, streamline workflow, and increase productivity in laboratory operation.
- Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
- Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
- Writing wraparound IQ/OQ and PQ equipment validation protocols and associated reports.
- Accompany vendors and ensure that all documentation is completed prior to and during vendor service engineer site visits when performing routine calibration, qualification, requalification and/or preventative maintenance activities in the QC laboratory.
- Generation and resolution of protocol discrepancies and deviations that arise as required.
Skills:
- A minimum of 4 years’ experience in a similar role
- Subject matter expert for CSV Computer systems validation.
- In-depth knowledge of Annex 11 and CFR Part 11 requirements.
- Experience at executing validation, data management and data integrity
- Knowledge of the methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
- In-depth understanding of current regulatory requirements for cGMP laboratory equipment validation.
Please apply now with your CV to be considered for this long-term opportunity.
The candidate must have the rights to work in the location stated in the job advert.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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