Vacancy expired!
What You Will Do
- Provide validation support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced and / or modified within the client organization.
- Work on software validation and qualification based on client policies and procedures and external regulations and policies.
- Be responsible for ensuring GxP computerized systems (includes hardware and software), are validated and controlled in compliance with industry guidelines.
- Perform computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews
- Author Standard Operating Procedures (SOPs), Work instructions, Guidelines and templates in the context of Software Development Life Cycle (SDLC) and computer systems validation/assurance
- Ensure adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines
- 10-15+ years of Computer System Validation experience
- Experience with cGxP, 21 CFR Part 11, GAMP and other compliance regulations and procedures
- Experience investigating and troubleshooting automation and control systems (root cause analysis)
- Ability to work in cross-functional team environments as well as independently
- Strong written and verbal communication skills
- Experience with attending external audits from agencies such as FDA, MHRA, etc will be a plus
Vacancy expired!