Vijay Kumar
Senior Manager
- Role
- Senior Manager at Apitoria Pharma Private Limited
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Vijay Kumar
Experienced professional with a demonstrated history of working in the pharmaceuticals industry and subject matter expert in mutagenicity assessment by read across and insilico models and Nitrosamine impurities risk assessment and deriving control limits and risk mitigation and ascertaining its root causes. Providing complete control strategy about impurity management. Well versed in API development starting from literature search to DMF filing and Life cycle management. Skilled in regulatory deficiency management with all regulatory bodies such as FDA, EMA, ANVISA, China FDA etc.Skilled in predicting excipient interactions and solving chemistry related issues in formulation processes.
Experience
Senior Manager
Apitoria Pharma Private Limited
Oct 2024 — Present
Providing comprehensive risk assessments and control strategies related to mutagenic and nitrosamine impurities and regulatory agencies queries.
Education
Osmania University
Masters in chemistry
University of Hyderabad
PGDPM
2013 — 2014
Skills
- Uv/Vis
- Glp
- Oncology
- R
- Analytical Chemistry
- Nmr
- Validation
- Medicinal Chemistry
- Regulatory Affairs
- Purification
- Technology Transfer
- Drug Discovery
- Organic Synthesis
- Chemistry
- Chromatography
- Gmp
- Corrective and Preventive Action (Capa)
- Pharmaceutical Industry
- Sop
- Fda
- Hplc
- Organic Chemistry
- Formulation
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