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Search Results for Validation Specialist
Validation SpecialistValidation Specialist Our client, a global pharmaceutical company based in Dublin are currently recruiting for a Validation Specialist to join their team on a permanent basis. The Validation Specialist will be part of the Technical Department and will report directly into the Validation Manager. Responsibilities • Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP) • Validation/Qualification projects will be across a range of production ...
Validation ManagerValidation Manager Our client a global pharmaceutical company based in Dublin is currently recruiting for a Validation Manager to join their team on a permanent basis. The Validation Manager will manage and coordinate the activities of the Technical services team which is made up of a Validation Specialist group and a Development lab group. Responsibilities • Formulate and plan development studies to support new product introduction, continuous improvement and company research objectives • Carry out validation activities as outlined in the Site Validation Policy a...
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Validation Specialist Career Profile
Validation SpecialistValidation is a Quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders. A highly technical position, the validation engineer completes or oversees all the calibration and testing of the various instruments and pieces of equipment. Validation is associated with all aspects of medical device industry from laboratories, manufacturing to computer software
Key Responsibilities of the Validation Engineer
- The execution and completion of process, systems and equipment validations and revalidations in accordance with Validation Master Plans, schedules and Company policy.
- Co-ordinate activities in all areas of validation
- Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
- As assigned, participate in cross functional teams to establish validation strategies and objectives to support the business
- As needed, assist in providing related training and support.
- Provide guidance and support to all departments/staff as needed regarding related issues, ensuring compliance, as applicable, with ISO13485 and all other Quality Standards, Validation Regulations and Guidance Documents.
- Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.
- Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.
Participate in/Lead the review of validation practices in the company; monitor trends, and initiate improvement opportunities.
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