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.
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