* Industry Pharma/Biotech/Clinical Research
* Work Experience 5+ years
* City Dundalk
* State/Province Louth
* Country Ireland
Job Description
We are currently hiring a Senior QA Validation Specialist for our Dundalk site, an exciting opportunity to grow your career with a leading Biotech consultancy.
The Quality team has a great opportunity for a Quality Assurance Senior Specialist at our Dundalk facility.
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.
Bring energy, knowledge, innovation to carry out the following:
Education background/ Experience
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.
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 trouble shooting and problem‑solving skills. Knowledge of formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc.
Skills
* Independent and self‑motivated.
* Able to multi‑task in fast‑paced, dynamic working environment.
* Strong planning, organisational, and time management skills.
* Critical thinking skills.
* Able to operate across functional boundaries, both internal and external.
Other requirements: On‑site (working time).
Job 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 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 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 performance management, recruitment, and training.
* Other quality activities as needed and assigned.
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