Exicutive to Ass.Manager - CSV

Person should have Knowledge on following:-

• Having Excellent Experience in Computer System Validation

• Preparation and review of Computerised system Validation Plan, and Validation Summary Report.

• Review of High Level risk Assessment includes GxP Assessment and GAMP categorization, criticality Assessment, ERES Applicability Assessment etc.

• Should have experince in variuos Software Development Life Cycle (SDLC), Like Waterfall, V-Model, and Agile methogology

• Should be Expertise in documenting/review of requirement specifications (User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS) documents).

• Expertise in documenting Design Review and Qualification Protocol, Technical Writing. Excellent experience as Validation Specialist and in-depth involvement in writing test scripts for Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

• Expertise in documenting Risk Assessment, 21 CFR Part 11 Assessment, Security Assessment, and documenting as per GAMP 5 guidelines.

• Hands on experience in Testing of various applications and developed Test Plans, deliverables, and documented the User Acceptance Testing based on the User Requirements and assessed the risk and security aspects for the application.

• Providing the guidance/support to internal teams for external/Regulatory Audit preparation/Audit compliance.

• Experienced in Periodic review to confirm that the computerized system remains in a valid state and are compliant with regulatory and standard requirements.

• Review of Defect/Deviation management and CAPA Management.

• Prepare and Review Data Migration Plan, System Retirment Plan with their summary Report.

• Variuos Models or Cloud computing like SaaS, PaaS, IaaS and their Validation Approach.

• Experience in Developing and enhancing the Standard Operating Procedures (SOPs) as a part of the SOP program.

• Well versed with MS Office. Excellent oral and written communication skills.