Deepak Bageshwar
GCP / PV Auditor | Certified ISO 9001 Lead Auditor
- Role
- Senior Manager - Global Pharmacovigilance Quality & Compliance at Apcer Life Sciences
- Location
- Nagpur, MH, IN
- LinkedIn followers
- 500 followers
About Deepak Bageshwar
15+ years of experience in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) Quality Assurance and Compliance• Skilled in risk-based GCP and GVP audit planning, execution, and reporting• Experienced in hosting client audits and GCP/pharmacovigilance regulatory inspections• Expertise in quality systems including CAPA, deviations, change control, training, and document management• Certified ISO 9001:2015 Lead Auditor with hands-on experience in quality system implementation• Successfully led ISO 9001:2015 certification implementation in the current organization• Strong knowledge of global regulatory requirements (ICH, EMA, FDA)
Experience
Senior Manager - Global Pharmacovigilance Quality & Compliance
Apr 2023 — Present · Nagpur, IN
Education
University Department of Pharmaceutical Sciences, Nagpur University
Bachelor of Pharmacy, Pharmaceutical sciences
2003 — 2007
Bharati Vidyapeeth's College of Pharmacy, Navi Mumbai
Master of Pharmacy, - Pharmaceutical Sciences, Quality Assurance Techniques
2008 — 2010
Skills
- Clinical Research
- Capa
- 21 Cfr Part 320
- CRO
- Ich Guidelines
- Biotechnology
- Risk Management
- Pharmaceutical Industry
- Sop
- Deviation Management
- Quality System
- Ich-Gcp
- Emea Guidance
- Regulatory Affairs
- Change Control Management
- Glp
- Watson Lims
- Management Training Programs
- Pharmaceutical Research
- Validation
- Software Validation
- 21 Cfr Part 50
- CRO Audits
- Oos
- Bioanalysis
- Gcp
- 21 Cfr Part 312
- Regulatory Submissions
- 21 Cfr Part 58
- 21 Cfr Part 54
- Analytical Chemistry
- Quality Management System
- Pharmaceutics
- 21 Cfr Part 11
- Anda
- Change Control
- Usfda Guidance
- Hplc
- Schedule Y
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