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QA Specialist

Quality & Laboratory
Cork
Siobhán Lane
Permanent
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Job Reference: JO-2005-65190_1589538146

Summary:

Responsibilities:


* Participation on Quality Product key activities for the assigned products including Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR, as applicable;


* Generate and or approve Validation Master Plans, Process Validation Protocols and reports.


* Provide appropriate Training on Quality systems and cGMP;


* To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible or in which participates.


* Support site audits and ensure the maintenance of the company QMS, collaborating to ensure audit readiness at all times.


* To ensure the QMS on site is maintained to corporate and international guidelines and changing regulatory guidelines


* To ensure that the site is audit ready


* To assure that all implemented procedures are followed on the site, according to each product requirements;


* To manage all quality activities for the products assigned;


* To promote the importance of high quality levels and the importance of a continuous improvement culture in all core company activities.



Requirements:


* University degree in Chemistry, Chemical Engineering, Pharmacy or equivalent degree in a scientific area.


* 3 years' experience in a GMP environment


* Regulatory Affairs basic knowledge


* Ability to discuss cGMP and technical aspects with clients and suppliers.



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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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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