Scientist III, Compendial development Laboratory in Hyderabad, India
- Pharmatroniks Jobs
- Jun 29, 2020
- 2 min read
Scientist III, Compendial development Laboratory
Scientific
Hyderabad, AP
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ID:IND 202
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Full-Time/Regular
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
This is a non-supervisory position in in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing USP/NF/FCC method development and method validation projects and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business and the incumbent is expected to support monograph modernization initiatives.
Roles and Responsibilities
Literature search for the USP/FCC/NF projects
Responsible for sample preparation (extractions such as liquid-liquid extraction, QuEChERS, or SPE and clean-up procedures) for food samples.
Should have worked on Chromatography (HPLC, GC), Mass spectrometry (LC- MS/ MS GC- MS/ MS ) techniques.
Should have experience of method development and validations for food ingredients and food products.
Responsible for Design and review of method development experiments and perform method validation in accordance with laid down procedure.
Responsible for preparation of method validation protocols and reports.
Provide effective technical and scientific expertise for development of Foods related analytical methods.
Engage in project planning, execution, method development and validation according to set standards as USP general chapters, guidelines, SOPs and protocols.
Responsible for providing the project updates supervisor on the regular basis.
Effectively coordinate with Group Leader to complete the USP/ FCC/NF projects within timelines.
Responsible for preparation and review of SOPs, protocols, reports etc.
Responsible for review of the records and documents.
Responsible for ensuring calibrations of the equipment as per the schedule.
Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.
Responsible for indenting the required glassware, chemicals and columns for the USP/FCC/NF projects.
Responsible for maintaining GLP & safety procedures while working in Lab.
Required Skills
1. Master’s Degree in Chemistry with 5-7 years of experience. Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices.
2. Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity. Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
3. Good analytical skills in handling method development and Validations for Food ingredients and food products. Should have exposure to GMP/GLP environment and documentation procedures. Awareness of ISO/IEC 17025 is desirable.
Required Experience
1. Master’s Degree in Chemistry (Food Science/Analytical/Organic) or Pharmaceutical Sciences with 5-7 years of experience or PhD with at least 1-3 years of
2. experience in relevant field. Exceptional breadth of food industry experience. Excellent technical writing and oral communication skills required. Must be able to communicate effectively with diplomacy and enthusiasm.
3. Technical and analytical skills required including the ability to interpret technical information. Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS-MS, GC, GC-MSK-MS, IC, ICP-OES/MS, FTIR, UV-Visible. Should have fair understanding of GLP regulations and exposed to external regulatory audits
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