CSV lead

CSV LeadLocation: San Francisco, CA, United StatesContractTechnical Skills Required:Computer System ValidationLife cycleProcess ValidationRisk AssessmentFDA standardsTest PlanningCorrective Action PlanExperience in CSV for equipment Domain: BiotechnologyProject Management skills and Team handling would be preferredNon-Technical Requirements:Communication SkillLocation PreferenceIn-Tangible skill requirementRequired Experience:8+ years of experience in CSV Implementation with at least few equipment validation experienceEnsure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master PlanPerform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validationDraft SOPs, writing scripts for IQ, OQ, PQ and handling CSVHelp, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.Provide training related to computerized systems validation, quality and compliance to users and appropriate personnelExperience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systemsResponsible for review & verification of Corrective Action Plan for auditsPerform periodic review/monitoring of computer systems implementedProven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process