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QA Specialist II

Quality & Laboratory
Therese Keohane
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Job Reference: JO-2003-65061_1583928709



* Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as it pertains to a wholesale distribution operation.

* Maintains routine programs and processes to ensure high quality products and compliance with current Good Distribution Practice (GDP) and Marketing Authorisations.

* Supports the Responsible Person (RP) on site as well as working cross-functionally with warehouse and customer service personnel as well as facilities, EHS and validation colleagues

* Supports site operations from a QA perspective

* Participates in developing Standard Operating Procedures (SOPs) and others types of documentation to ensure quality objectives are met.

* Reviews shipping records, environmental monitoring and associated data relating to distribution activities.

* Works directly with operating entities to ensure that internal audits on site are conducted on a continuing basis to ensure compliance to GDP requirements.

* Participate in preparation for and during internal and corporate audits as well as regulatory inspections of the site.

* Participates in the development & delivery of training programs regarding relevant to site operations.

* May conduct or serve as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to site operations.

* Conducts gap analyses and supports risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards

* Participate in local and corporate projects and process improvement initiatives, as required


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

* Familiar with the concepts of supply chain dynamics between freight forwarders, carriers and handlers related to the supply and delivery of pharmaceutical materials would be beneficial

* Demonstrates proficiency in Good Manufacturing Practices (GMPs).

* Demonstrates strong knowledge of Six Sigma, Lean and root cause analysis tools used for identifying and correcting deviations

* Demonstrates audit and investigation skills, and report writing skills.

* Demonstrates strong verbal, technical writing 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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Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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