Validation Consultant

• May 2022 - Present

QA Auditor

• Nov 2021 - May 2022

QMS:Design, planning, implementation, training and management of Quality Management System,Smartsolve Management - User Management (User Creation, SSO & Account Preference Set up, Roles Creation, Position Creation, Assign roles to User, Assign Rights Groups to User, Search for User Record - Setup, User Account Modification, Termination of User, Inactivation of Role, Troubleshooting), Document Management (Create New Document, Linking References, Quality Check, Guidance on Document management on roles: Author / QC / Approver, Document Expiry), Training Management (Assigning Training roles, Revoke of Training Assessment, Search Person Training, Search for User Training),Audits: Handling Audits, Guiding Business Units on Audits, Guiding Compliance Team on QMS Activities, Conducting Internal Audits, Guiding people on addressing Audit points, Preparation of robust QMS.

Business System Analyst (Pharmacovigilance and CSV)

• Jun 2020 - Oct 2021

Training: Training Management, Guidance on Templates & materials on trainings, Ensuring 100% training Compliance (Learning Edge & Smartsolve), Guiding Team on LMS (Learning Edge) & QMS (Smartsolve) tools based on User requests.Handling CSV activities: SDLC Documentation for Computerized system in accordance with established procedures, quality standards and regulatory requirements, Generate and execute verification and validation (Validation Plan, Risk Assessment, IQ, OQ, PQ, RTM, Validation Report) documentation for GxP computerized systems, Maintain Validation schedule and prepare status reports, Support various regulatory inspections and internal audits.Pharmacovigilance: Monitoring and reporting valid, non-valid AEs & Special Situations from social media and worked on data sets like: Patient Medical Records, Faxes, Audio Records, Mails based on PREP criteria in AE tracker dashboard.

Software Engineer

• Dec 2019 - May 2020

QMS Modules: NC, CAPA, Complaint, Document, and Training Management - Involved in workflow configuration, forms, and entity design, involved in Testing the QMS tool, Preparation and Review of CRP Scripts, User Guides, Test Scripts, PQ Script

Technical Writer

• Jan 2017 - May 2019

Validation: Monthly validation planner, Preparation and review of Protocols and Reports related to Process Validation for new and site transfer products, Regulatory Submission documents, Continued Process Verification, Market Equivalency and Hold Time Study.Regulatory: Addressing the validation related deficiency for ANDA submission (like IR & CR query) through regulatory documents.Training coordinator: Handling of all training-related activities with the help of Training Master Application (TMA).Software's handled: Track wise, Minitab, PACE, and TMA

Executive (Tech Transfer)

• Mar 2016 - Dec 2016

Site Transfer Projects - Techpack evaluation (API, Excipients, Validation documents, regulatory documents and all the project documents), License Application, Project Management, Preparation of costing formula, gap analysis, review of raw material specification, finished product specification, supplier COA’s and finalization, item code creation – raw material and SFG codes. Site Transfer Projects - Techpack evaluation (API, Excipients, Validation documents, regulatory documents and all the project documents), License Application, Project Management, Preparation of costing formula, gap analysis, review of raw material specification, finished product specification, supplier COA’s and finalization, item code creation – raw material and SFG codes.

Documentation Executive

• Apr 2013 - Mar 2016

Review & prepare BOM/MFR including SAP activities, Creation of Bill of Materials & Recipes, Involved with pilot plant scale-up activities involved for site transfer products and new products, Dealt with documentation which involves preparation and review of SOPs and batches records, Involved and supported the team during troubleshooting investigation.Preparation of MBRs (Master Batch Records) like MFR, PORM, MI, and PI for new products (based on inputs received from R&D) and for site transfer products (based on executed batch records of donor site).Preparation of Process validation protocols and reports for Confirmatory, Exhibit, Pre-validation, Validation, and Commercial batches.Preparation of In-process hold time protocols, Stability protocols, and reports.Preparation of miscellaneous documents like SHE Report, Equivalency Report/Justification Report, Cleaning validation checklist, Process flow charts, and Review of stability batch data of technology transfer products.Manufacturing Execution System: Designing of MBRs based on the MFR, Reports, and other site executed batch records for new products as well as for Site Transfer Products.Designing MBR by mapping the Business Process, Formulation, and PAS|X system requirement.Performing mock execution of the MBR, to ensure the correctness of the prepared MBR along with CFT.Follow-ups and interacting with CFTs, Werum & resolving issues related to MBR.Interaction with production, warehouse, and designing MBR as per requirements for creating efficient MBRs.Impart training to the relevant departments prior to the start of batch execution activity.Identification of problems during real-time execution of batches and rectification of eMBR related issues, Knowledge of change control, deviation, CAPA, OOS, OOT, and Incident reporting, Preparation of URS, QRM for the equipment.

Trainee

• 2010 - 2011

Batch Records preparation for Active Pharmaceutical Ingredient (API) Manufacturing Batch Records preparation for Active Pharmaceutical Ingredient (API) Manufacturing