Lab System Validation

o Experience/ exposure to Computerized System Validation (CSV), US

FDA 21 CFR

Part 11, EU Annex 11 and GAMP 5. o Experience of CSV Validation in any one of the Lab systems is must. o Should worked in pharmaceutical domain and its related knowledge is must o Good communication and technical writing skills are a must o Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and Google Cloud Platform environments. o 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. o

CSV, GAMP 5 CPFR

Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred. o To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas o Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement. o Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc. o Exposure to Regulatory Audits and Remediation activities o Ensure the CSV artefacts are in line and meets regulatory requirements o Preferred Experience in Agile Development o Knowledge on working in Jira / Service Now o Adaptation to AI is preferred. Testing (in addition to above) o Experience in testing and knowledge in any one of the QC/R D Lab systems is must. o Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must. o Knowledge on working in Jira, HP ALM or any automation testing tools.