Quality Assurance Senior Specialist
We are currently recruiting for an exciting opportunity in the pharmaceutical industry based in Ireland.
This position is ideal for professionals looking to join a top-ranked company who excel in their field.
The role involves overseeing all validation activities to ensure compliance with current regulatory requirements, cGMP and company standards. This includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
* Ensure quality oversight of qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, CTUs and shipping processes.
* Review and approve validation documentation and associated data, including plans, URSs, quality risk assessments, protocols and reports, to ensure conformance to SOPs, specifications and other applicable acceptance criteria.
* Provide QA oversight, review and approval of events/deviations, investigations and change evaluations during qualification/validation activities.
* Review SOPs relating to qualification/validation activities.
* Support in Regulatory inspections and Client audits.
* Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, CTUs and shipping processes.
* Coordinate QA Validations activities to ensure schedule adherence and on-time delivery of project deliverables.
* Manage and develop the QA Validations team, including performance management, recruitment and training.
Requirements:
* Bachelor's degree in a Scientific or Engineering related discipline.
* At least 3 years of experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/medical device manufacturing in a FDA/EU regulated environment.
* Thorough understanding of validation requirements associated with a cGMP manufacturing facility.
* Strong technical aptitude and deep knowledge of GxP regulations applicable to biologics manufacturing.