Dnyandeo Rathod

To lead the Quality function in an organization as per cGMP regulations by executing experience, Knowledge, Skills & do the significant contribution to the organization to achieve organization goals and personal goals.

• Involved in activity like Analyst, Reviewer, Planning, Batch release, Investigation of OOS, OOT & lab incidents & QAMS activity like deviation & change control, CAPA, QRM, WS Preparation etc.
• Knowledge of Stability Study program. AMV, TT, FP Section & Microbiology Section & GLP section, WS Preparation. Method validation protocol & report preparation, Stability protocol & Stability summary preparation.
• GC & HPLC related data such as Assay, RS, Dissolution, CU, BU, RM analysis data etc. LIMS activity, SAP activity, Releases & COA Preparations. Complete Analysis of Finished Product, Stability study, In Process samples of Tablet, Capsule, Injection & Complete Analysis of Raw Materials and

• Responsible for Analytical QA/QMS including OOS, OOT & OOC investigation, review and approve.
• Responsible for evaluation, Review and approval of Change control, deviation, CAPA and incidence.
• Responsible for Analytical AQA. Review and approval of AMV, CSV, cleaning validation and process validation protocols & reports
• Responsible for review and approval APQR
• Responsible for perform risk assessment of elemental Impurity and Nitrosamine impurity.
• Responsible.
• Regulatory Audit: Recently face surprise USFDA and then EDQM Audit.
• USFDA Audit passed with status VAI.
• Invalid OOS and critical Deviation independently explained to USFDA inspector
• Audit Experience: Independently can faced Regulatory Audits like USFDA, EDQM, MHRA, WHO & customer Audits etc. Confidant to deal with auditor, to convince, explain & justification, Recording of Audit observations and audit compliance report preparation with supporting documents like impact assessment, risk assessment, protocol based activity with adequate CAPA.
• Software Knowledge, Validation, & implementation: LIMS, QMS, E-DMS, SAP, ELN, e-LOG, LMS, Chromeleon, Empower, Lab Solution, Timo, ELN etc.

• Lupin Ltd, 6 years, Sr. Executive QC, Aurangabad, MH
• Sun Pharma Ltd., 2 Years, Officer QC, Vadodara, GJ
• Wockhardt Ltd., 4 Years, Officer QC, Aurangabad, MH
• Novartis India Ltd., 1 Year, Executive QC, Mumbai, MH
• Aurobindo Pharma Ltd., 1 Year, Sr Executive QC, Hyderabad, AP

• Responsible for -all QA & QC department activity like planning, review, release of batches, approvals and archival of documents
• Responsible for QMS documents like change control, deviation, OOS, OOT, CAPA and incidence timely closing, conduct internal audit, face external audit, Company PPT presentation, to give audit response, implement audit observations.
• Responsible for QA Activity such as Daily work planning, Approvals, document revisions SOP, STP, BMR, BPR, Protocols, Process validation, method validation Cleaning Validation etc.
• Responsible for APQR, Vender Qualification, market complaint, Audit trial review, etc.
• Responsible for Equipment qualification, Calibration & preventive maintenance and maintain schedule.
• Responsible for Document archival, Document destruction as per SOP.

• Star winner for Leader plus in 2016 (Lupin)
• USFDA Audit 09 time exposer, 54 % lab incidences Reduced in lupin, 21 Calculation excel sheets are created and validated, Number of ideas implemented in lab to system improvement, 15 raw materials done Reduce testing with QRM, 100 SOPs revised, training, implemented and uploaded in e-DMS, No. of CAPAs implemented.

• GC (Make- Agilent 6890A, 7890A with Chromelion & Empower3).
• GC (Make: Shimadzu- 2010 with GC solution Software).
• HPLC (Make: Shimadzu & Dianex with Chromelion software)
• HPLC (Make: Agilent 1200 Series & Waters with Empower3 & chromelion software) Dissolution (Make: Electro lab)
• UV Spectrophotometer (Make: Shimadzu UV 1700)
• FTIR (Make: Shimadzu).
• Potentiometer, KF Auto titrator (Lab India), Polarimeter, (Shimadzu).

• Total Experience: 16 Years QC & QA (Formulation OSD & API)
• Date of Birth: 04/15/80

GAMP-5, Python , Regulatory Affare