HART BIOLOGICALS Salary
2 RIVERGREEN BUSINESS CENTRE QUEENS MEADOW HARTLEPOOL TS25 2DL ENGLAND
TIN: 04520394
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Earnings on positions in HART BIOLOGICALS
HART BIOLOGICALS is looking for employees for positions:
validation engineer
Working hours
- full-time | Permanent
Responsibility
- create and maintain the Validation Plans and Reports for processes, software, and products
- assist the Quality Manager in the management of other QMS documentation requests related to the Validation, Projects, Products and Risk management
- take the lead on validation activities for the processes and software related to product design together with creation and execution of validation protocols, reports, CSV, URS, and other appropriate documentation according to the company templates
- create a plan for necessary revalidation activities based on risk assessment for all equipment, processes, and software
- handle changes according to company SOPs and work cross functionally with other teams to fulfil necessary actions and documentation needs to stay in compliance with relevant standards and regulations
Requirements
- certified ISO 13485 Auditor Training
- risk Management training according to ISO 14971
- strong knowledge of ISO 13485 and US FDA 21 CFR Part 820 especially within the Validation activities area
- performing Validation and Change control in MD and/or IVD or similar industry is necessary
- strong organizational and problem-solving skills in a fast-paced environment
- performing risk management activities
- ability to work to tight deadlines and deliver exceptional work when required
- NCR and CAPA management
Education
- degree or equivalent in an Engineering, Science or Clinical subjects, experience in the Medical Device and or In-Vitro Diagnostics industries in similar position