Visual Quality Assurance Specialist
1 week ago
Job Title: Visual Inspection Engineer
We are seeking a skilled professional to support the manufacturing operation of a leading biologics company based in Sligo.
- Support visual inspection operations in line with all safety, regulatory, and organizational requirements.
- Develop and modify procedures as needed to support the Manufacturing Process.
- Participate in Process Validations efforts and projects implementations.
- Review and approve process-related commissioning, qualification, and validation protocols for completeness and accuracy.
- Execute protocols in a timely basis to meet the project schedule requirements.
- Establish, lead, and optimize the process for certification of technicians for visual inspection.
- Establish and maintain the defect library.
- Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements.
- Provide technical input to guide the development of SOPs for Visual Inspection.
- Lead manufacturing and validation activities during project life cycle.
- Coordinate with internal/external stakeholders for the evaluation of particles/defects.
About Us:
- A relevant third-level qualification in an engineering, science, or technical discipline (Degree Level or Masters Preferable)
- At least three (3) years of total combined experience in Technical/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization
- Experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilization operations preferable
- Candidates must have the correct visa to live and work in Ireland
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