Are you looking for your next long term assignment?
I am supporting Quanta's Global BioPharma client in their search for a QAV Specialist.
The Engineer will work as part of the QAV Team providing quality oversight to Core / Capital Business Projects and should have experience supporting a CQ function from quality perspective.
Responsibilities & Experience:
- Able to confidently and accurately review/approve CQ documentation alone.
- Happy to support PQ generation and execution.
- Responsible for the execution, review and approval of other validation activities in a GMP regulated environment.
- Performing and reviewing (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by client.
- Developing validation plans for specific system implementation projects.
- Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
- Identify and implements improvements to the QA Validation systems.
- Degree in Sciences or Engineering.
- 5 + years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Generalist, Enthusiastic, Task Orientated, Team player.
If you are interested in discussing this position, please submit your profile and I will be in contact at my earliest convenience.
This client will only consider candidates currently based in Ireland.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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