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Exciting opportunity to work with one of the countries biggest pharmaceutical companies. Our Partner in the Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.
Currently they are looking for Quality Specialist to joining their team.
Essential Duties and Responsibilities for this Quality Specialist role include, but are not limited to, the following:
- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records
- Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer
- Provide guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted
- Provide support for audits of EP/ExP and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted
- Support routine analytical change requests and support process modification change controls
- Annual Product Review assembly
- Support document requests for regulatory filings and post approval changes
- Gap remediation plans, Quality Risk Management data inputs and data integrity gap assessments
- Receive and share Quality Alerts and Quality Bulletins with EP/ExP
- Closely collaborate with appropriate business/operations and technical areas to achieve company objectives.
- You are likely to have a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
- Experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
- Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.
- Possess strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Senior QC (Quality Control) Compliance Specialist - Republic of Ireland A Leading midlands-based biotechnology organization requires a Senior QC (Quality Control)Compliance Specialist to
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