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Validation SME - CSV - Pharma - ISO - GMP - HVAC - Freelance/Contract -New Jersey
Robson Bale are looking for a Validation SME to come on board for an initil 6 month contract in New Jersey.
6 months, market rate.
This role is on-site in New Jersey
Tasks and Responsibilities
- Act as a Subject Matter Expert in the process validation project of our client
- Perform gap assessment for the applications in scope and validate them leveraging the pilots validated for the CSV Remediation project
- Define the qualification framework in the process validation, review supplier documentation, create qualification deliverables and validation plans
- Complete risk assessment, reporting
- Analyze and evaluate process data from executed validation studies.
- Support the Quality team in all validation topics
- Have a good understanding of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP
Requirements
- Previous experience as an SME in a similar position, preferably in Pharma/Manufacturing environment
- Previous experience as a Quality Manager
- Previous experience as an Equipment Qualification SME
- Strong experience in process validation and project quality management
- Excellent knowledge of GMP, HVAC qualification - devices and Software; ISO 14644-1
- Experience with Telstar is an advantage
- Familiarity with Pharmaceutical regulations such as GxP and documentation required
- Attention to detail and the ability to communicate well across all levels of the organization
- Excellent English (spoken and written)
- Candidates have to declare Criminal record extract not older than three months
6 months, market rate.
This role is on-site in New Jersey
Validation SME - CSV - Pharma - ISO - GMP - HVAC - Freelance/Contract -New Jersey
Robson Bale Ltd
