Summary:
Our client, a biopharmaceutical company based in Dundalk, has a great opportunity for a
Quality Assurance Senior Specialist
. This role is responsible for overseeing all validation activities, ensuring compliance with current regulatory requirements, cGMP, and company SOPs. It includes validation/qualification activities for facilities, utilities, equipment, computerised systems, cleaning processes, storage areas, controlled temperature units (CTUs) and shipping.
Responsibilities:
* Ensure quality oversight of qualification and validation activities for all facilities, utilities, equipment, computerised systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units, CTUs, and shipping processes.
* Ensure that all validation documentation and associated data, including but not limited to plans, URSs, quality risk assessments, protocols, and reports, are reviewed and approved by QA for conformance to SOPs, specifications, and other applicable acceptance criteria.
* Ensure that all events or deviations, investigations, and change evaluations that occur during qualification or validation activities have appropriate QA oversight, QA review and approval, and adhere to SOPs and cGMP requirements.
* Review SOPs relating to qualification and validation activities.
* Provision of support during regulatory inspections and client audits.
* Provision of QA validations expertise to maintain the validation status of the facility.
* Maintain an understanding of cGMP regulations and guidance in relation to all aspects of validation and/or qualification of facilities, utilities, equipment, computerised systems, cleaning processes, manufacturing processes, storage areas, CTUs, and shipping processes.
* Coordinate all QA validation activities to ensure schedule adherence and on-time delivery of project deliverables.
* Manage and develop the QA validations team, including, but not limited to, performance management, recruitment, and training.
Qualifications & Experience:
* B.Sc. or B.Eng. in a scientific or engineering-related discipline, for example, biochemistry, chemistry, or engineering.
* Experience in a Quality Engineering, Quality Assurance, or Quality Validations role for biologics or related pharmaceutical or medical device manufacturing in an FDA and EU-regulated environment.
* Thorough understanding of the validation requirements associated with a cGMP manufacturing facility.
* Knowledge of GxP regulations applicable to biologics manufacturing, for example, 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 and FMEA