Purpose
QA CSQ/CQV specialist contractor/Consultant reporting to the QA CSQ/CQV Lead. The role is 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 the provision of QA oversight to the Commissioning, Qualification and Validation (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
* 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, 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/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.
* Review SOPs relating to qualification/validation activities.
* Provision of support in regulatory inspections and client audits.
* Provision of QA validations expertise to maintain 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, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
* Coordinate all QA validations activities to ensure schedule adherence and on time delivery of project deliverables.
* 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.
Qualifications
* B.Sc or B.Eng in a scientific or engineering related discipline (e.g., biochemistry, chemistry, engineering).
* 4‑5 years experience in a quality engineering/quality assurance/quality validations role for biologics or related pharmaceutical/medical device manufacturing in an FDA/EU regulated environment.
* Thorough understanding of the validation requirements associated with a cGMP manufacturing facility.
* Strong technical aptitude is required.
Special knowledge
* 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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