Title: Computer Systems Validation Analyst
Location: South San Francisco
Type of role: Contract 1-2+ year’s
ideally want a validation professional with experience with Veeva. Tracelink, ComplianceWire, or Veeva QMS.
The Computer System Validation (CSV) Analyst s responsible for GxP system validation activities and ensuring computer systems follow applicable regulations including GAMP5, FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11. This role is also responsible for the development of Standard Operating Procedures (SOPs) and templates specifically related to software validation and testing. Duties include executing the validation of new systems; ensuring / verifying compliance with appropriate regulations and maintaining required change control procedures. The CSV Analyst will develop design and test documentation including user requirements, risk assessments (RA), test plans, Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification (DQ/IQ/OQ/PQ) tests and validation summary reports.
- 4-5+ years of experience in the Pharmaceutical or Biotech industry Strong knowledge of FDA regulations and experience in implementing 21 CFR Part 11 following GAMP concepts.
- Must have profound knowledge of the FDA, EMEA and International regulations regarding Computer Systems.
- Knowledge of CSV requirements and procedures (IQ/OQ/PQ) for on-premise and SaaS solutions.
- Strong experience with performing change controls, drafting UAT’s and performing risk assessments.
- Knowledgeable of FDA, GxP, EMEA and International related regulations and guidelines such as GAMP and ICH and ISO. Specific knowledge of computer validation methodologies and principles is a must
- Working, hands-on, knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems).
- Strong organizational, communication (written and oral), and interpersonal skills. Team oriented, dependable, self-starter.
- Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies.