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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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