Contributing to the preparation and review of the Validation Master Plan
Managing the preparation, review and issuing of Validation Protocols and Reports
Generating Validation Documentation including Risk Assessments, Traceability Matrices, and Validation Reports.
Reviewing and Approving Specifications associated with Equipment, Processes, Products and Computerised Systems.
Implementation of Process Validation of new products
Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams
Establishing, implementing and directing validation and revalidation activities.
Liaising with contract manufacture customers in seeking their approval for protocols and reports where appropriate
Managing the validation requirements of company and third party suppliers and Contract Manufacturer Organisation’s.
Working directly with a cross functional team to define inputs and requirements to the MVP.
Reviewing and managing Change Control Forms for Validation/Compliance implications.
Conducting Routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
Updating existing quality documentation related to validation activities.
Identifying training requirements in support of validation.
Conducting Risk Assessments.
Requirements:
Bachelor's degree in Science, Engineering, Technology or a related discipline.
5 years’ experience as a Validation Engineer in the Medical Devices or related Healthcare industry.
Experience of GxP Computerised Systems
Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.
Familiar with the GAMP5 Guidelines.
Excellent communication skills, including ability to advise and influence
Excellent understanding of validation concepts and documentation
Package:
€65k - €75k Basic salary
Permanent Position
Company Benefits
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Job Description
Contributing to the preparation and review of the Validation Master Plan
Managing the preparation, review and issuing of Validation Protocols and Reports
Generating Validation Documentation including Risk Assessments, Traceability Matrices, and Validation Reports.
Reviewing and Approving Specifications associated with Equipment, Processes, Products and Computerised Systems.
Implementation of Process Validation of new products
Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams
Establishing, implementing and directing validation and revalidation activities.
Liaising with contract manufacture customers in seeking their approval for protocols and reports where appropriate
Managing the validation requirements of company and third party suppliers and Contract Manufacturer Organisation’s.
Working directly with a cross functional team to define inputs and requirements to the MVP.
Reviewing and managing Change Control Forms for Validation/Compliance implications.
Conducting Routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
Updating existing quality documentation related to validation activities.
Identifying training requirements in support of validation.
Conducting Risk Assessments.
Requirements:
Bachelor's degree in Science, Engineering, Technology or a related discipline.
5 years’ experience as a Validation Engineer in the Medical Devices or related Healthcare industry.
Experience of GxP Computerised Systems
Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.
Familiar with the GAMP5 Guidelines.
Excellent communication skills, including ability to advise and influence
Excellent understanding of validation concepts and documentation
Package:
€65k - €75k Basic salary
Permanent Position
Company Benefits
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical