R. MOGANAVEL

Thirsty enough to proceed challenges and barriers leading the destination beyond obstacles. Having high Degree of interpersonal and communicative skills, ready to take up suitable assignments in IT CSV of high growth Oriented pharmaceuticals and R&D Centre.

• Post graduate in Chemistry Over24 years of experience in Bulk drugs and Formulation QC/QA, and AR&D Labs and as IT CSV consultant.
• Currently Working as CSV consultant Lead in Qx Technologies for Novartis US leading the responsibilities of validation, for business applications in HPALM and coordination through the phases of SDLC activities CSV are performed in HPALM
• Excellent understanding of the software Development Life cycle (SDLC) as per GAMP5 guidelines
• Review of Validated Computer Systems in compliance with21 CFR Part11 and GxP FDA Regulations for CSV activity
• Abundant experience in generating and reviewing Computer Systems Validations (CSV)
• Exposure in system IT Retirement activities of business applications
• Expertise in conducting the Risk assessment as per21 CFR part11
• Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, , SOPs, Protocol for SRS, Deviation, Risk Assessment, Decommission report, Periodic Review Report.
• Deliverables according to21 CFR Part11 and FDA regulations in the Pharmaceutical industries
• Working knowledge of GLP, GMP, GAMP5 guidelines especially in the areas of computer or related systems
• Exposure in performing the CSV activity for Laboratory instrument as per GAMP5 Guidelines
• Excellent exposure in IT change management, audit compliance.
• Experience in reviewing all documents, protocols and SOP's to ensure they meet GxP and FDA regulations
• Experience in Developing and reviewing User Requirement Specifications (URS) , Functional Requirements Specification (FRS) and Requirement Traceability Matrix (RTM) Documents
• Good experience in Gap Analysis and documenting Remediation Plan
• Excellent Knowledge and experience in Good Documentation Practices
• Demonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies and improve quality.
• Exposure in the guidelines of computer software assurance (CSA)
• Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems.
• Well versed with MS office ,excellent oral and written communication skillss

• Work experience in USFDA, MHRA, WHO .MCC Audits exposure and cGMP regulated companies internal audits.
• Able to execute independently validation protocols for validation of Analytical methods for routine quality control analysis as per USFDA and ICH guidelines for all product parameters.
• Ensuring lab compliance as per regulatory requirement (GLP
• Ensuring21 CFR part11 compliance in QC lab.
• Preparation of instrument IQ, OQ, PQ protocols and execution of the protocols for all instruments and equipments
• Conducting induction training for new joiners of the department.
• Member of self-inspection team for conducting internal audits.
• Planning Day to day activities to the team guys through LIMS & organizing for training wherever required.
• System implementation as per regulatory requirements.
• Supporting the analytical data to be submitted for ROW market Customer.
• Handling and resolving the customer query which are related to analytical data.
• Exposure in the Lab support team in QC and taking over the responsibilities of calibration, Qualifications and compliance in the laboratory
• Faced the internal and external audits with zero observations during my career in FDA audits

• USFDA
• WHO
• MHRA
• MCC
• EU-GMP
• TGA