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Senior QA Specialist - CMO

Quality & Laboratory
Siobhán Lane
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Job Reference: JO-2009-65367_1599030530



* Work in an FDA / HPRA approved Drug Product Intermediate (DPI) and Active Pharmaceutical Ingredient (API) manufacturing facility;

* Ensure compliance to new and established systems, global regulations and guidelines for a wide range of DPIs, APIs and intermediates;

* Promote a mature quality culture;

* Issuance, control and review of production batch records;

* Manage and maintain CMO oversight (Technical Transfer, Batch release, Change control, equipment validation and qualification, process validation)

* Responsible for review/approval and release of all batches produced at CMO site;

* Responsible for review/approval and release of API's; Pre-QP batch record review for DPIs

* Review and approve change controls

* Lead and participate in validation activities including issuance of process validation protocols, reports and VMPs;

* Participate in cross functional teams for the introduction of new products/processes;

* Preparation/approval of cleaning documentation;

* Participate in cross functional investigations, advise on corrective actions and assist with their implementation;

* Carryout GMP training;

* Participate in all aspects of audits by Regulatory Authorities and Customers;

* Conduct internal audits as per agreed schedules;

* Deputise in the absence of other Quality Assurance Specialists when requested to support site activities or CMO activities ;

* To take reasonable care for your health and safety and for others in the workplace.


* B.Sc. Degree in a technical or scientific based subject - Chemistry, Biochemistry, etc.;

* Minimum of 6+ years in a QA Specialist or Quality role in a Regulated Pharmaceutical Industry (API and/or DP manufacture);

* Competent and knowledgeable of all relevant ICH guidelines, particularly ICH Q7A, EU GMP guide annex 18, and all FDA requirements relating to 21 CFR 210 and 21 CRF 211;

* Experience in direct customer engagement

* Experience with approval of final release & sign-off of batches

* Flexibility is essential;

* Proven ability to work on own initiative and excellent decision making

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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