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QA Specialist

Careers at Fastnet
Cork
Chantelle Morrissey
Contract
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Job Reference: JO-2403-66639_1711534959

Summary:

QA Specialist

Cork, Ireland

12 Month Contract

Our pharmaceutical client is looking for a QA Specialist to support Packaging and Labelling Operations for 12 months to join their team!

The successful candidate will be required to perform QA approval and release of primary and secondary packaging components, QA review and approval of packaging and labelling documents, procedures, and GMP deviations.

Responsibilities

* Performs a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements.

* Participates in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.

* Participates in reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.

* Performs QA review and release of primary and secondary packaging components.

* Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions

* QA Review and approval of GMP Deviation investigations and CAPAs

* QA Review and approval of Master data and recipes required for operations

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

Requirements

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

* Prior experience in pharmaceutical industry is preferred (ideally within a QA role)

* Demonstrates proficiency in Good Manufacturing Practices (GMPs).

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

* Demonstrates working knowledge of FDA / EMEA standards and quality systems.

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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