Validation SME - CSV - Pharma - ISO - GMP - HVAC - Freelance/Contract -New Jersey in Bucuresti

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 -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