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QA Specialist III (Senior)

Quality & Laboratory
Cork
Siobhán Lane
Temporary
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Job Reference: JO-2008-65347_1598276342

Summary:

Responsibilities:

* Participates within inter-departmental and cross-functional teams

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

* Reviews routine data for release of starting materials / packaging components

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

* Identifies problems and generates alternatives and recommendations

* Serve as a lead of investigations and corrective and preventive action (CAPA) plans

* Completion of routine to more complex/non-routine projects/assignments

* Normally receives very little instruction on routine work, general instructions on new assignments

* Writes and/or implements changes to controlled documents

Requirements:

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

* 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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