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QA Specialist

Quality & Laboratory
Cork
Siobhán Lane
Temporary
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Job Reference: JO-2006-65238_1592387804

Summary:


Responsibilities:


As part of team of other QA specialists, the candidate may be responsible for performing a wide variety of activities to ensure compliance with applicable regulatory requirements:


* Participates in the writing of annual product reviews and gathering relevant data from the quality system and related departments.


* Complies and presents reports on site quality system metrics.


* Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).


* Coordinating or leading investigations and corrective and preventive actions (CAPA).


* Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met


* Provides support for onsite departments in assessing and approving quality system records such as deviations, change controls and document updates.


* Supports complaints investigations with visual assessment of returned complaint samples to determine any counterfeit material.


* Participates in the development of training programs regarding all aspects of producing quality products.



Requirements:


* 4+ years of relevant experience in a GMP environment related field and a BS.


* 2 + years of relevant experience and a MS.


* Prior experience in pharmaceutical industry is preferred


* Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.


* Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.


* Demonstrates strong verbal, technical writing, presentation and interpersonal skills.



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


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Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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