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Job Title: Validation/CSV Lead

Location: **ONSITE** El Segundo, CA

*COVID vaccination required

JD:

Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

• Experience of CSV Validation in Lab systems (LIMS, CDS, SDMS etc) and any diagnostic software like QPCR, QxMGR is added advantage
• Should worked in pharmaceutical domain and its related knowledge is must
• Good communication and technical writing skills are a must
• Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and Google Cloud Platform environments.
• Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
• CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle
• To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
• Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
• Prepare and execute SCA, URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix, FRA / FEMA
• Exposure to Regulatory Audits
• The service will benefit if knowledgeable about and capable of advising on product & ingredient regulation within the industry (not mandatory).
• Using previous use cases and best practice counsel on highly regulated environments
• Ensure the CSV artefacts are in line and meets regulatory requirements
• Preferred Experience in Agile Development
• Knowledge on working in Jira / Service Now