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GxP Validation Manager/lead with 21 CFR part 11, FDA predicate rules expertise, GDP, Clinical system knowledge, good communication skills, understanding of Clinical systems, Clinical eco system, Validation life cycle including IQ./ OQ / PQ, Validation plan, Validation summary report , Manage customer stakeholders, support Functional risk assessment, support CR / projects as required. Building and managing validation processes, validation planning, running re-validations, vendor assessment and audit, GxP assessment and estimation for GxP projects

Must have strong Validation and Gxp Experience.

Building and managing validation processes, validation planning, running re-validations, vendor assessment and audit etc.

Must have knowledge on MES.

Must have knowledge on 21 CFR Regulations.

Must have experience on Validation life cycle including IQ. / OQ / PQ, Validation plan, Validation summary report, manage stakeholders, support Functional risk assessment, support CR / projects as required

Good knowledge on SDLC phases.

Good knowledge on Test Management tools like JIRA, HP ALM.

Must have great communication skills.