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Senior QA Specialist - CMO

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

Summary:


Responsibilities:


* 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.



Requirements:


* 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



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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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