Safety Quality Control
Resume:
HIMANSHU SHARMA
Bennettsville, SC
*******@*****.***
To work for an organization which gives me ample opportunity to explore and showcase my capabilities, skills and in turn whatever I do, I ensure that I do it in the best possible, effective and an ethical manner. Willing to relocate: Anywhere
Authorized to work in the US for any employer
Work Experience
Senior Associate Scientist
WIPRO - New Delhi, Delhi January
2010 to June 2018
- To perform Individual Case Safety Report (ICSR) and to close processed ICSRs.
- Database entry of ADR and SAE in the internal safety database (Argus ver.4.2)
- MedDRA coding and structured narrative writing, Seriousness, expectedness and causality assessment.
- Worldwide literature search, Draft Periodic Safety Update Reports (PSUR) and Annual Safety Reports.
- Report safety information to Regulatory Authorities. Formulation Scientist
MENTHOLATUM - Scotland. October
2006 to December 2009
- Manufacturing of topical creams, emulsions, gels and ointments as per SOP under cGMP and UKMHRA.
- Maintenance of batch records, JDE’s, requisition records and SHE records. Production Pharmacist
Wings Pharmaceuticals - Delhi, Delhi January
2003 to July 2005
- Worked in the In Process Quality Control (IPQC) under WHO- cGMP guidelines for the testing of pharmaceuticals under production, taking samples from the running machines and documenting the results.
- Prepared SOPs of batch production of tablets, capsules, ointments, syrups.
- Also supervised the other departments of Pharmaceutical production, such as Granulation section, packaging section and inventory control.
Education
Master's in Immunopharmacology
UNIVERSITY OF STRATHCLYDE - Glasgow, SCOTLAND
August 2005 to September 2006
Bachelor's in PHARMACY
S. B. S (P.G) I. B. M. S - Dehradun Ho., Uttarakhand August 1998 to July 2002
Skills
ARGUS V4.2-7, MS-Office, MedDRA coding, Medical writing, In-Process Quality Control, c-GMP, c-GCP, BMR, JDE, SHE
(10+ years)
Assessments
Indeed Assessments are tests that job seekers can use to demonstrate their knowledge and abilities. Written Communication — Proficient
Jan 2019
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Jan 2019
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Jan 2019
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Technical Expertise Of Instruments/Equipment
§ INDUSTRIAL:
- Kilo-ton vessels for heating, mixing, homogenizing, sifting, Hot- air ovens, HEPA.
- Rotary tablet machine, Capsule filling machine, Blister packaging.
§ LABORATORY:
- RT-PCR, Western and Northern Blotting.
- Analysis and quantification of antibody isotype using ELISA.
- SDS-PAGE.
- Cell culture techniques using micro-titer plates.
- Dose response assays on isolated organs using and handling lab animals.
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