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Hyderabad
Sridhar Reddy Yatharla

Sridhar Reddy Yatharla

Involved Green Field Projects and CSV Projects.

Pharmaceutical / Bio-tech

Hyderabad, Hyderabad

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Services offered

Key Expertise: QMS: 14 years hands-on experience handling Quality notifications (OOS, OOT, Deviations, Change Controls, Incidents, CAPA, Vendor Audit reports) through SAP.

Validations: Analytical, Process, Cleaning, Equipment, Instrument, CSV (S/4 HANA, Empower, QC Instruments, Process equipment).

Regulatory Audits: USFDA, MHRA, TGA, Health Canada, PMDA, ANVISA, Romania, WHO & NABL. (500+ audits)

Vendor Management: 250 + Vendor Audits (API, Excipients and Packaging).

Leadership: Established Commercial Testing Laboratory from zero customers to 250+ and revenues from zero to 30lakhs. Through this employment created from 3 to 40 personals in the laboratory in the course of 2.8 years.

Consultant: Execution of Greenfield projects (Ensured Procurement/Vendor Qualification/establish QC/QA/Admin/Engineering/Process Procedures), Driving CSV Projects, GAP Assessments. Part of SDLC project (Royal Quality Pillars) through QA testing (Dev/QA/Prod). SAP S/4 HANA (Retrospective Validation) performed at Indian Immunologicals Limited.

Vendor management
Project management
Consultant
Quality management
Regulatory audits
Approximate rate: ₹ 1,500 per hour

Experience

24+ years of Pharma.

Education

CSV Certificate(U/P)

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