CSV Consultant - Katalyst Healthcares & Life Sciences
Plainsboro, NJ 08512
About the Job
Responsibilities:
- We are seeking a highly skilled CSV (Computer System Validation) Consultant with expertise in GxP (Good Practice) and SOX (Sarbanes-Oxley) compliance to join our team. The ideal candidate will be responsible for ensuring that our clients' computer systems comply with regulatory requirements, industry standards, and best practices. This role involves working closely with cross-functional teams to develop, implement, and maintain validation strategies and documentation for regulated systems.
- Develop, execute, and maintain validation plans, protocols, and reports for GxP and SOX compliant systems.
- Conduct risk assessments and gap analyses to identify potential compliance issues and develop mitigation strategies.
- Ensure that all computer systems are validated according to regulatory requirements, including FDA, EMA, and other relevant authorities.
- Collaborate with project teams to integrate validation activities into the overall project lifecycle.
- Provide guidance and training to internal teams and clients on GxP and SOX compliance requirements and best practices.
- Perform audits and assessments of computer systems to ensure ongoing compliance.
- Prepare and present validation documentation to regulatory agencies during inspections and audits.
- Stay current with industry trends, regulatory changes, and advancements in technology related to computer system validation.
- Support the development and implementation of quality management systems and processes.
- Assist in the development of Standard Operating Procedures (SOPs) related to CSV activities.
- Bachelor's degree in computer science, Information Technology, Engineering, Life Sciences, or a related field.
- A minimum of 5 years of experience in computer system validation, with a focus on GxP and SOX compliance.
- In-depth knowledge of regulatory requirements and guidelines, including FDA 21 CFR Part 11, EMA Annex 11, and SOX.
- Proven experience in developing and executing validation plans, protocols, and reports.
- Strong understanding of risk-based validation approaches and quality management systems.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
- Certification in GxP or SOX compliance is a plus.
Source : Katalyst Healthcares & Life Sciences