Manik Raj — Associate Consultant

● Application administrator for Equipment’s and Instruments. ● Involved as a lead in the CSV, CSA, QMS and IT Compliance activities. ● Involved in the validation activities of SAP projects. ● Developing and maintaining GAMP lifecycle documentation, including user requirement Specifications, functional specifications, risk assessments, and traceability matrices. ● Develop and execute validation Activity and Ability to leading team members. ● Preparing and Revising the Operational SOP’s. ● Developed validation master plans, IQ, OQ, and PQ protocols, and summary reports. ● Review URS, FRS, FRA, Design Documents (HLD, LLD), Configuration documents, Stage gates, Build Completion Summary. ● Skillful knowledge of Change control, Release Management, Disaster Recovery, CAPA and Defect management. ● Writing and Review of Validation Plan, Test Scripts (IQ, OQ, PQ), Validation Summary Reports. ● Having good communication skills and client interaction. ● Established procedures for Regulatory operations by coordinating with SME of the department. ● Involved in multiple projects to validate regulated Computer Systems within the Regulatory, Patient safety and Medical Information areas. ● Experience in Software Validation and GxP systems ● Experience in System Assessment against Compliance requirements. ● Verifying documents in compliance perspective of company policies, procedures and obtain appropriate compliance approval in a timely manner. ● Experience in managing requirements traceability information and track requirements status throughout the project. ● Good understanding of SDLC validation (V model) process. ● GAP Analysis/assessment of legacy systems as per regulatory requirements. ● Ensuring the quality of the deliverables across all the phases. ● Having expertise knowledge in 21 CFR part 11 assessments (ERES assessments), EU Annex 11 assessments, GxP/Compliance assessments, GAP Assessments (identifying gaps) Independent review of the project deliverables to ensure they meet FDA regulatory expectations and standards and Providing guidance to Project teams on process and compliance. ● Coordinates drafting, reviewing and approval for all the validation deliverables to achieve the project timeline. ● Hands on experience in Life Science Validation Testing and its processes.

Stackforce AI infers this person is a Validation Consultant with expertise in GxP compliance and regulatory systems in the Healthcare sector.

Location: Hyderabad, Telangana, India

Experience: 9 yrs 11 mos