Description
Description:
- Continuous Improvement Focus
- Conduct validation activities in compliance with US and EU relations, GBSC procedures and EHS requirements
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements
- Develop validation documentation as required (eg specifications, plans, protocols, procedures)
- Develop pFMEA documentation to support processes as part of Validation process
- Review and approve documents prepared by the validation team, other departments and contractor organisations (eg commissioning test plans, impact assessments, change controls)
- Execute qualification protocols as required
- Compile relevant documentation from contractors, suppliers and other departments for inclusion in reports
- Generation/Modification of Process Specifications as required
- Prepare and execute validation protocols/reports
- Initiate and implement change control activities in accordance with site procedures
- Develop validation plans for site and projects as part of validation planning or re-validation activities as appropriate
- Track and resolve exceptions during qualification activities
- Coordinate qualification activities with engineering, construction and commissioning activities
- Coordinate qualification activities with contractors and vendors as required
- Coordinate qualification document review and approval
- Collate and organise qualification files for turnover to QA DC/route of PLM
- Participate in cross-functional teams as required
Technical Skills and Additional Details
- Knowledge of bespoke validation. Process knowledge and documentation.
- In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Working experience of validation computer systems for use in a FDA regulated environment.
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
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