Overview
Ref. 01320
Senior QA Validation Specialist
Exciting opportunity with our client, a leading multinational pharmaceutical company, for an experienced Senior QA Validation Specialist to join their team at the Dundalk facility.
Reporting to the QA CSQ/CQV Lead, the successful candidate will be responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. This includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units (CTUs) and shipping.
An important aspect of this role is provision of QA oversight to the CQV activities associated with the Dundalk Facility start-up project and supporting the transition from project phase through to sustaining phase with respect to validation activities
Responsibilities include but are not limited to:
* Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
* Ensure that all validation documentation and associated data, sech as plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications and other applicable acceptance criteria.
* 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, controlled temperature units (CTUs) and shipping processes.
* Ensure that all events/deviations, investigations, and change evaluations that occur during qualification/validation activities have appropriate QA oversight, QA review and approval and adhere to SOPs and cGMP requirements.
* Manage and develop the QA Validations team including, but not limited to, activities such as performance management, recruitment, and training.
* Other quality activities as needed and assigned.
Requirements:
* B.Sc or B.Eng in a Scientific or Engineering related discipline (e.g. biochemistry, chemistry, engineering).
* Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment.
* Strong knowledge of the validation requirements associated with a cGMP manufacturing facility.
* Strong technical aptitude.
* Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and the industry standards applicable to validation, including but not limited to; GAMP, ISPE, ISO, ASME and BPE.
* Knowledge of troubleshooting and problem-solving skills.
* Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc.
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