USP Technical Associate Job Vacancy Announced – Apply Now
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.
Job Title: Technical Associate
Location: Hyderabad, India
This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing USP/NF and 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.
Eligibility Criteria:
Master’s Degree in Chemistry with 1-3 years of experience. Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices. Exposure to GMP/GLP/QMS environment and documentation procedures and champions data integrity. Should be capable of performing analytical method developments and method validations using modern techniques and protocols. 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.Preferred Qualifications
Master’s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 1-3 years of experience. Excellent technical writing and oral communication skills are required. Must be able to communicate effectively with diplomacy and enthusiasm. Technical and analytical skills are 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, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible. Should have a fair understanding of GLP regulations and be exposed to external regulatory audits
Roles and Responsibilities
- Literature search for the USP/NF/FCC projects.
- To ensure the project’s requirements by coordinating with the Group Leader.
- To involve in project execution, method development, and validation of USP/ NF/FCC projects.
- To ensure the knowledge on different drug products handling and samples preparations.
- Provided effective technical and scientific expertise regarding drug substance and drug product analytical development
- Engage in project planning, execution, method development, and validation of projects according to set standards as USP general chapters, guidelines, SOPs, and protocols.
- Ensure the project updates are provided to the supervisor regularly.
- To coordinate with Group Leader to complete the USP/ NF/FCC projects within timelines.
- Responsible for preparation and review of SOPs, protocols, reports, etc.
- Responsible for the review of the records and documents.
- To ensure that the calibrations of the equipment are performed as per the schedule.
- Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
- To indent the required glassware, chemicals, and columns for the USP/NF/FCC projects.
- To maintain GLP & safety procedures while working in Lab.
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