Job Title:
QAV Engineer
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Job Description:
The QAV engineer will be responsible for the validation and quality assurance of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards. Key responsibilities include coordination and direction in the validation and quality assurance process, as well as generation and maintenance of Site Validation Master Plans.
The ideal candidate will possess excellent analytical skills and strong communication abilities, with a proven track record in ensuring compliance to regulatory standards.
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Requirements:
To be considered for this role, applicants must have a qualification or degree in an engineering or scientific discipline, along with at least 3 years of experience in medical device plastics processing, moulding or assembly operations. A strong understanding of cGMP and regulatory requirements is also essential.
In addition, successful candidates will demonstrate expertise in generating and maintaining Project Validation Plans and schedules, as well as producing high-quality validation protocols and final reports.
* Qualification and/or degree in engineering or scientific discipline
* 3 plus years of validation/Quality experience in medical device plastics processing, moulding or assembly operations
* Strong knowledge of cGMP and regulatory requirements relating to the medical device industry