Quality Assurance Role Tipperary

Quality Specialist

  • Posted Feb 22, 2021
  • Tipperary
  • Contract
  • VAC-18894

An External Quality Specialist required by a Pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution. The facility takes in raw chemicals and ships finished medicines to end users. This site has grown from an API site, to a strategically important campus that supports critical stages of the company's drug lifecycle. Come join this people focused, innovative, flexible, fast paced team as they work in this critical role.

Excellent opportunity for an External Quality Specialist.

In this new role the Quality Specialist will work with / as part of External Quality Assurance team with responsibility for ensuring that products are manufactured, packaged, analyzed, released, stored, and distributed in accordance with business expectations and all applicable regulatory requirements.
o 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.
o 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.
o Provide guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted.
o Provide support for audits and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.
o Support routine analytical change requests and support process modification change controls.
o Annual Product Review assembly.
o Support document requests for regulatory filings and post approval changes.
o Gap remediation plans, Quality Risk Management data inputs, and data integrity gap assessments.
o Receive and share Quality Alerts and Quality Bulletins.
o Closely collaborate with appropriate business/operations and technical areas to achieve business objectives.
o Ensure both operational knowledge and technical skills are maintained and compliant against individual training requirements.

The Quality Specialist requires:
o BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
o Minimum of 5 years' 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.
o Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities. coaching, motivation, communication and negotiation.
o Possess a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a total Quality Operations.
o Experience in SAP and Trackwise & Lean Six Sigma.
o Thorough knowledge of all aspects of EM management, supply chain, and operations, including engineering, materials, R&D, production, etc.

Call Katie Brown at LSC on 021 4777 329 for more information on this new Quality Specialist position or apply directly via this advert.

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