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Regulatory compliance expert

York
beBeeCompliance
Posted: 31 July
Offer description

Quality Assurance Specialist

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* Ensure compliance with SOPs, GMPs and applicable regulations by reviewing batch documentation.
* Review and approve production and analytical documentation to ensure conformance to appropriate SOPs, GMP and regulatory requirements.
* Collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
* Identify compliance gaps and make recommendations for continuous improvement.
* Perform and review complaints and deviation investigations, change controls and CAPA's.
* Assist in the induction process for new starters and training of other staff.
* Compile data for reports and presentations, provide data interpretation, draw conclusions.
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Required Skills and Qualifications:

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* Degree in a Quality, Science or Engineering discipline.
* 3+ years of industrial experience in the pharmaceutical/chemical industry or government drug-regulatory agency.
* Effective communications (oral/written) and interpersonal skills are necessary.
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Benefits:

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The successful candidate will have the opportunity to work in a dynamic environment and contribute to the company's success.

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Others:

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Additional activities may be assigned by the manager/supervisor.

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