Tenthpin 

provide expertise for Quality compliance for critical implementation for multiple enterprise application implementations, IT Consulting, life sciences consulting , GAMP 5 ver 02 Regulatory compliance

Advisor

Infosys

worked with global Medical devices and consumer health MNC to support provided project management compliance as a PQM/ OQM/SQA role

Senior Consultant

Cognizant

Worked as a team lead for supporting clients in enterprise implementation for EQMS, LIMS, CTMS, EDMS, MES, supported various regulatory audits, also part of  CQA team performing onsite CSV audits

Lead life sciences consultant 

Datalynx Group

Designing strategy for Global Implementation of GAMP category 4 Projects like Manufacturing Execution System PAS - X 3.1.7
Responsible for providing overall regulatory compliance during project life cycle.
authoring various deliverable like Validation plan, Test Strategy plan, Risk assessment, test scripts for IQ/OQ/UAT, summary reports, Validation Reports, SOP's
providing support and guidance during regulatory inspections

Senior CSV SPECIALIST

Self-Employed

designing strategy for CSV project, provide support in delivering as per regulatory norms & GAMP 5 req. providing supplier audit services for same domain.

freelance CSV Consultant

Covacsis Technologies Pvt. Ltd.

Review domain aspect for new product development ,
Support business analyst team in designing customer's specification
Strategic analysis for QMS implementation
Provide technical inputs to sales team in site visits
To make a software application compliant with 21 CFR parts 11 , Good Practices in Software Validation
Defining strategy for implementing Computer System validations compliant to GAMP 5 Approach

Lead - CSV 

RPG Life Sciences

Supplier Qualification , regulatory audit compliance , Quality risk management , facility validation
QMS implementation

Assitant Manager - Quality Assurance

SHARON BIO MEDICINE

EXECUTIVE-QA

Lok-Beta Pharmaceuticals (I) Pvt. Ltd.

implementation of various GMP system, & leading company for PICS GMP certification.handling various regulatory queries from 
CIS, & SEMI-REGULATED pharmaceutical world.deals with local regulatory bodies for licensing & COPP related activities.

Assistant manager - Corporate Quality Assurance

Zydus NYCOMED Healthcare Pvt Ltd

to prepare & review various quality related documents as per ICH Q7, to prepare organization for various regulatory & customer audit, technology transfer, validation

officer QA

Experience life science professional of around 17 years in industry, handled domain of Gxp validation & data integrity consultant.
currently works in domains of Computer Systems Validation, since last 8 years. have successfully implemented various enterprise level application for Pharmaceutical, medical devices and clinical organizations.
the expertise for CSV includes defining business requirements for software apps, strategic decision making/ planning for GxP application followed by risk based approach based on GAMP 5. Apps implemented SAP ECC 6.0,Labware  LIMS, Trackwise 8.0, LMS, DMS, HPLC- shimadzu, Labsolutions,  Manufacturing Execution System, werrum PAS-X 3.1.7. providing compliance as per 21 CFR parts 11 & EU annex 11, GDPR

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