Our South Dublin-based client is looking for a Senior QA Specialist to join their team on a 12 month contract. The candidate must have at least 5 years’ experience in cGMP Pharmaceutical Operations is essential including direct experience with Quality systems.
Role Summary:
Reporting to the Quality Manager, the Senior QA Specialist is responsible for managing and executing QA operational 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 compliant continuous improvement activities. This is a management role with direct QA Specialist reports and with a focus on delivering a High Performance Quality Culture and development of staff.
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. Authoring and development of QA SOPs and controlled documents.
* Develop and own Quality metrics for the organisation. Use data to drive delivery of Quality records on-time and a high-performance culture.
* QA SME for Quality Risk Management activities including leading and, where appropriate, facilitating QRM activities in line with ICH Q9 rev1.
* Identify and implement continuous quality system improvements and support implementation of improvements in GxP Compliance, Preventive Maintenance, Deviation Management, Change Control Programs and other GxP Systems.
* Quality Assurance (QA) oversight, on-site manufacturing operations, internal materials management, warehousing operations, and quality control testing activities.
* Quality Assurance (QA) oversight, of operational activities which occur at approved service providers (QC testing, material storage, material supply, etc.).
* Contribute to and execute assigned inspection readiness activities, regulatory inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
Requirements:
* At least 5 years’ experience in cGMP Pharmaceutical Operations is essential including direct experience with Quality systems
* Primary Degree in scientific discipline or equivalent
* Experience in managing and developing staff
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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