QAV Specialist
- Cork
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
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.
The Candidate
- 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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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
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
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