Amol Dumbre
Quality Specialist - Bioequivalence
- Role
- Senior Executive Quality Assurance at Macleods Pharmaceuticals Ltd
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Amol Dumbre
Experienced with a demonstrated history of working in the research industry. Skilled…
Experience
Senior Executive Quality Assurance
May 2022 — Present · Mumbai, IN
o Develop and maintain fit for purpose Quality Management System for activities performed by operation teams which falls under the scope of principles of GCP/GLP/GVP.o Conduct of Audit(s) for both bioanalytical and impurities studies executed at bioequivalence division. o Perform routine audits of operation team at defined frequency to identify any gaps, risk in process and support in minimizing risks and process improvement.o Perform Vendor Qualification Audit and Quality Governance through vendor specific program.o Conduct periodic audit trail review of various instruments, equipment and software utilized for both clinical and bioanalytical studies.o Perform trend analysis of deviations occurred during the operation and their CAPA through routine track record.o Review and prepare the SOP and EOP.o Review and prepare BTIF (Bioequivalence Trial Information Form) and DBE summaryo Conduct training of operation team on in-house SOP’s and EOP’s.o Conduct audits of calibration of instruments and equipment.o Assist Information technology team to conduct Computerised System Validation.o Ensuring anytime Audit readiness, by developing systems to track projects and documenting the audit as per the visit of agency.
Education
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
M. Pharmacy
2010 — 2013
Pune University
Bachelor of Pharmacy
2005 — 2008
NCRD'S Sterling Institute Of Pharmacy - India
Diploma in Pharmacy
2003 — 2005
Skills
- Formulation
- Glp
- Hplc
- Lc-Ms
- Dissolution
- Pharmaceutical Research
- Mass Spectrometry
- Pharmacokinetics
- Chromatography
- Anda
- Regulatory Submissions
- Bioanalysis
- Drug Delivery
- Regulatory Affairs
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