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Safety Quality Control

Location:
Bennettsville, SC
Posted:
October 05, 2019

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Resume:

HIMANSHU SHARMA

Bennettsville, SC

adaivy@r.postjobfree.com

+1-843-***-****

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

View my full results at: https://share.indeedassessments.com/share_assignment/673mv40o6anljgvn Problem Solving — Familiar

Jan 2019

View my full results at: https://share.indeedassessments.com/share_assignment/9yy3duzz7-nz8jqq Organizational Skills — Proficient

Jan 2019

View my full results at: https://share.indeedassessments.com/share_assignment/ku6hscfuczitznyl Indeed Assessments provides skills tests that are not indicative of a license or certification, or continued development in any professional field. Additional Information

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.



Contact this candidate