Lab System Validation

Roles & Responsibilities:Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.Experience of CSV Validation in any one of the Lab systems is must.Should worked in pharmaceutical domain and its related knowledge is mustGood communication and technical writing skills are a mustDeveloping validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP 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. Adaptation of CSA and Module Validation is preferred.To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areasProvide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc.Exposure to Regulatory Audits and Remediation activitiesEnsure the CSV artefacts are in line and meets regulatory requirementsPreferred Experience in Agile DevelopmentKnowledge on working in Jira / Service NowAdaptation to AI is preferred.Testing (in addition to above)Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must.Knowledge on working in Jira, Client ALM or any automation testing tools.