Senior Recruitment Consultant @ PE Global
The role:
PE Global is currently recruiting for a QA Validation Specialist on behalf of a leading pharmaceutical company based in Dundalk. This is an initial 11 month contract role.
Description:
The QA CSQ/CQV specialist will be reporting to the QA CSQ/CQV Lead. This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. It 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 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 validation 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, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (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 validation team including, but not limited to, activities such as performance management, recruitment, and training.
Education and Experience:
* 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 validation role for biologics or related pharmaceutical/medical device manufacturing in a FDA/EU regulated environment.
* Thorough understanding of the validation requirements associated with a cGMP manufacturing facility.
* Strong technical aptitude is required.
* 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up‑to‑date CV to kellie.hackett@peglobal.net.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Dundalk, County Louth, Ireland 1 week ago
#J-18808-Ljbffr