HRGO are recruiting a Validation Specialist on behalf of our client in Folkestone. The successful candidate will work with the Validation Specialist on Quality Management system improvements to existing processes, develops and executes process system validations, and provides manufacturing quality input to Product Development groups.
This role carries responsibility to comply with and promote compliance with the relevant GMP and hygiene procedures and standards in the activities they undertake within the facilities.
Key Responsibilities:
Work with the Validation specialists to manage the operational validation activities within the plant.
Conduct validation reviews - initial and annual.
Provide support to the Validation specialist to ensure that Root Cause/FMEA are followed and maintained.
To conduct regular site surveys to ensure that the site Validation Master plan is kept up to date.
Help to maintain a compliant validation strategy for the plant.
Provide support for operations on technical issue, projects and planned validation activity timelines.
Work with the Validation specialist to co-ordinate validation activities as required.
Personal Specification:
Broad experience of all key areas of Quality Assurance.
Working Knowledge of the MDD, MDR, 21 CFR 820, ISO 13485, ISO 14971, ISO 22716.
Experience of data analysis, data trending and preparing KPI's.
Experience in data analysis and review (including trend analysis) for communication to management teams
Excellent ability in communicating complex ideas across a range of groups.
Excellent interpersonal skills, being a team player and attention to detail.
Education & Experience:
University degree in a related field of Science or Engineering.
Professional typically with over 3 years of technical experience and a demonstrated track record.
Health & Safety:
To support safety as a top priority.
To ensure oneself and others is aware of, understands and follows all Company Health & Safety instructions.
To report any accidents or near misses to the Health & Safety Manager.
This is a fantastic opportunity so if you feel you have a relevant experience, please apply with an up-to-date CV. If you have not been contacted with a week, please assume you have been unsuccessful at this time.
