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Our South Dublin-based client is looking for a QA specialist to join their team in a permanent position. The candidate must have 3+ years of experience in cGMP Pharmaceutical Operations including direct experience with Quality systems.
Role Summary:
Reporting to QA Management, the QA Specialist is responsible for executing assigned QA tasks in the PQS, advising and partnering with personnel in Operations, Supply Chain, Quality Control and Engineering to execute tasks compliantly in the PQS and for identifying and delivering compliance continuous improvement activities.
Responsibilities:
* QA SME for key PQS systems including deviations, change control, complaints, validation, quality risk management related to manufacturing operations and facility, supply chain, QC, and GxP processes.
* Review and approval of Standard Operating Procedures and other controlled documents in the PQS.
* Support the QA leadership and QP team in relation to preparation and review of the relevant documentation for release activities.
* QA SME for Quality Risk Management activities including leading and, where appropriate, facilitating QRM activities in line with ICH Q9 rev1.
* Quality Assurance (QA) oversight, with Management support, of on-site manufacturing operations, internal materials management, warehousing operations, and quality control testing activities.
* Quality Assurance (QA) oversight, with Management support, of operational activities which occur at approved service providers (QC testing, material storage, material supply, etc.).
Requirements:
* At least 3 years’ experience in cGMP Pharmaceutical Operations is essential including direct experience with Quality systems
* Primary Degree in scientific discipline or equivalent
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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