Pradeep Kumar Setty
DATA INTEGRITY OFFICE I COMPUTER SYSTEM VALIDATION I QUALIFICATION & VALIDATIONS I QA L&D I DEVELOPMENT QA(DQA) I IPQA I STERILITY QA I AQA I MICROBIOLOGY I AUDITS I VENDOR QUALIFICATION
- Role
- Ass Manager, Di Office & Csv, Cqa at Biocon
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Pradeep Kumar Setty
As a experienced professional in the Pharmaceutical industry with 12+ years of experience, I have enhanced my expertise in Quality Management System, Computerized System Validation & Verification, Learning and Development Management, Risk management and Governance, Quality and Compliance in GxP, and Operational Excellence. My analytical and strategic thinking skills have enabled me to deliver impactful results in various business with in the organizations. I possess a dynamic and energetic approach towards work, which helps me drive teams towards achieving goals. My ability to ensure quality and compliance with industry standards has been crucial in maintaining a high level of operational excellence. With my diverse skill and strategic thinking experience, I am confident in my ability to make a positive impact and organizational goal achievement in an organization I work with. Experience: Microbiology & Testing with 5 years; Quality Assurance with 5 years and currently in CQA with 2years and counting. Skills: Experienced in Computer System Validation, Software Qualifications, Auditing and Compliance, Risk assessment & Management, Data Integrity Assurance, E-Training and Training Management (SAP SF vLMS), Handling Track wise, DMS, E-APQR, SAP SF vLMS, FileNet. Career Highlights-In DQA the document review time is harmonized having as SLA with the CFT decreasing the review time to 48Hours from 7days-Handling cases / trouble shoots of end user for SAP SF vLMS in timely manner & maintaining KPIs of 98% and higher consistently for 13 months across all sites for 10k end users- Actively and successfully collaborated with various stakeholders in problem investigation and derived for a logical conclusion in aseptic failures at various sterile facilities -Successfully was as a front room lead for a year and faced 5 USFDA and 1 MHRA successfully audits with ZERO delay in document sharing. Currently working as \"Data Integrity Office\" Team member at Biocon for multisite locations in drug substance and drug products formulations having vast knowledge in microbiology, QC (Chemical), IPQA, AQA, Retention sample management, Qualification & validations, CSV, QMS, DQA, RLD management, L&D, Soft ware qualifications, People Training, BABE Studies Monitoring, Audits and compliance, QMS Management, Regulatory audits, GxP Compliance, DI Audit and Risk Assessment & Managment.
Experience
Ass Manager, Di Office & Csv, Cqa
Apr 2023 — Present · Bengaluru, IN
Csv & csa i validations & qualifications i data integrity assurance i audits & compliance i gxp i risk managment i software qualifications i auditing i learning & development i training i qms i vendor handling i team managment & collabaration i strategic thinking
Education
Manipal Academy of Higher Education
Master's degree, Medical Pharmacology
2008 — 2012
Sri Bhagawan Mahaveer Jain College
Bachelor of Biotechnology, Industrial Biotechnology and Molecular Technics
2005 — 2008
Kishore Vidya Bhavan
SSLC, Biology/Biological Sciences, General
1990 — 2004
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