Nagnath Giram

To be recognized for competence, creativity and service in the areas of Pharmaceutical Project Management (cGMP software implementation), Computer system validation, Quality assurance and Quality Control functions. Aim to work a progressive organization for growth-oriented position that gives enough scope to sharpen my skill and technical knowledge to latest regulatory demands, at the same time to work towards the growth, Progress & Success of the organization. Upgrade professional skills in dynamic and innovative direction is zeal. Use of gained experience and skills in the pharmaceutical field with best possible way for achieving the GMP compliance with high Quality standards with business need. My vision is to be contributor in success journey of organization as a leader, performer, and responsible individual.

• Excellently implementation of MODA Software at 4 Injectable sites (Go-live) EM & Utility Segment.
• Integration of Automated colony counter with MODA Software. (First In Pharma Industry)
• Implementation Barcoding for sampling location and equipment for better compliance –Quality excellence.
• Implementation of Batch Record and Recipe Management in Documentum software.

• To facilitate and track the quality software projects (cGMP software’s) like LONZA MODA, DOCUMENT MANAGEMENT SYSTEM (DMS), SCAN PROOF SYSTEM (PRINT INPECTION), AND TRACKWISE.
• Understand the user requirement and create/configuration workflow as based upon the requirements shared by the user.
• To ensure project requirement met timely and gets completed within defined timeline.
• To ensure compliance of all the quality project software’s as per 21 CFR, part 11 and Annex 11.
• To co-ordinate with software developers for upgradation if required.
• To coordination with IT and other teams from corporate or sites for the development / implementation of various systems and software’s.
• To perform UAT for new software’s and after developing in existing quality software’s.
• To prepare the documents related to all quality software’s.
• To preparation scripts for qualification and verification challenge in quality environment.
• To validate/upgrade the software’s, Lonza MODA, Document Management systems (DMS) and Proof System as per validation master plan.
• To impart training to core team members at functional site for Lonza MODA, Document Management systems (DMS) and Scan Proof System.
• To prepare/revise/Review and implementation of the SOPs/Policies and standard practices related to software operation.
• Supplier/Vendor Assessment.
• To support to users for software’s related trouble shooting.
• To perform any other activity assigned by HOD, as required and support other CQ initiatives.

• SME For Lonza MODA Troubleshooting, Demonstration, Teaching and training to users
• Development of URS, IRA, FRA OQ & PQ script, RTM & Periodic revision report, Standard Operation Practices.
• Assessment of FS, CS VP IQ
• Project Scheduling, Tracking and Milestone Achievement
• Development & Implementation of Workflow.
• Troubleshooting & Mentorship, Demonstration and training to users and super users.
• To educate and capable the site user for operation of cGMP software.

• Blood Group: B -ve
• Date of Birth: 03/15/84
• Gender: Male
• Nationality: INDIAN

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