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QA Specialist II

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

Summary:

Responsibilities:



* 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




Requirements:


* 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.



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Talent Consultant:
Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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