Nagaraj M Email & Phone Number

Visakhapatnam, Andhra Pradesh, India

Vadodara, Gujarat, India

Ø Hands on experience on Labware 7 LIMS modules and MES projects.Ø Collaborate with system owner to create VP (Validation Plan) and develop URS, FRS (Functional Requirements), UAT scripts, IQ, OQ and PQ scripts.Ø Extensive experience in preparation and execution of Qualification protocols (IQ, OQ & PQ) for GxP systems.Ø To prepare and review of User requirement specifications, vendor evaluation questionnaire & checklists related to GXP, ERES and Data integrity. Ø Contribute in all areas of implementation including but not limited to Vendor interaction, system compatibility, qualification, deployment and training to end users and support on application.Ø Perform GAP assessment for GxP systems.Ø Validate and test deliverables to ensure business needs and requirements for application.Ø Installation of LIMS System-Have clear understanding in LIMS system preparation by downloading suitable fixes and modules from Labware Dev track. Ø Master data configuration and data migration.Ø Hands on experience in different Labware LIMS modules, such as Lot management, Stability management, Storage management, Inventory management (Columns, Chemicals, WS, STD, Volumetric solutions etc,)Ø Provide Strategic direction to the team and guide technical knowledge.Ø Manage and escalate risks/issues that impact the success of an engagementØ Preparation of Validation summary report and Traceability matrix.Ø Assist in working with business team to identify data needs in new Projects Implementation and MaintenanceØ Track and document project progress and issues.Ø To provide support to sites during audits for software (s) implemented as part of DigitalizationØ Integrated laboratory instruments Polari meter, PSD, FT-IR, UV, KF Titrator, Auto Titrator, Visco meter, Balances, Ph Meters, Conductivity meters, DT Apparatus, Halogen Moisture Analyser etc. with LIMSØ Validation of data migration activitiesØ Equipments management in MES.

Vadodara, Gujarat, India

Chennai, Tamil Nadu, India

Ø Responsible for preparation of Preventive Maintenance check lists for applicable Instruments/Equipments in QC lab.Ø Performance Verification of BOD Incubators, Walk in Incubators, LOD Oven, Muffle Furnace etc. (Temperature mapping)Ø Trouble shooting of analytical instruments (breakdown/maintenance).Ø Preparation & Review of quality risk assessments for laboratory instruments.Ø Installation & Qualification of laboratory Equipments/Instruments.Ø Computer System Validation (CSV) protocols preparation, review and execution for GxP systems.Ø To define and review the computerized systems qualification requirements as per ISPE GAMP 5 for assuring data integrity and reliability.Ø Develop, update and maintain all procedures related to the computerized systems. Ø To work closely with all departments to ensure the operation of a validated environment according to GMP and other regulatory requirements. Ø Review of qualification/validation of Laboratory instruments and assessment for its compliance to 21 CFR Part 11 and 21 CFR 211.68 requirements. Ø Review of computerized systems post go-live to ensure compliance with the applicable procedures. Ø Experience in all customer & regulatory audits (FDA, MHRA, Health Canada & TGA).Ø Data management in GxP systems (Projects creation, Backup, Restoration, periodic verification, Audit trail verification).Ø To perform Audit trail and periodic review of computerized system as per respective SOPs. Ø Verification of daily backup in Empower server & Symantec backup serverØ Certified on Empower 3 administration.Ø Strong knowledge in Empower User management, Lace boxes, Instrument connectivity & Firmware upgradation.Ø User management in all GxP systemsØ Hands on experience in all analytical Instruments applications (Empower 3, Tiamo, MagIC Net, TOC-L, Lab solutions, Spectrum ES etc.)Ø Experience in usage of Trackwise and providing investigation report with historical check.