The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post: Reference Standards Scientist II/III
Job Description:
Function of the Position:
This is a hands-on non-supervisory position responsible for the oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS). This incumbent is responsible for the timely preparation of procurement specification and collaborative testing protocols for new RS lots, technical assistance for collaborating labs, analytical data review and preparation of summary reports, preparation of packaging and Quality Control testing instructions, and assignment of periodic re-test intervals.
Roles and Responsibilities:
• Independently maintains successful scheduling operations, necessary documents, complete and accurate information, and addresses the quality issues to insure availability of reference standards in a complex portfolio.
• Addresses general customer technical inquiries and thoroughly investigates customer complaints with minimal guidance.
• Drafts planning documents, coordinates with labs, and reviews/interprets data from multi-laboratory studies.
• Compiles study summary reports for each RS lot.
• Provides correct guidance on the interpretation of test data. Proposes and designs studies to obtain necessary date to resolve complaints.
• Demonstrate technical understanding to internal and external audiences regarding USP's RS programs.
• Presents technical issues/presentations to inter-departmental USP staff.
• Facilitates additional cross-functional activities with other USP staff.
Candidate Profile:
Minimum Requirements:.
Ph.D. or M.Sc degree in Chemistry or Pharmacy, with 1-3 years or 4-5 years, respectively, of experience in pharmaceutical analysis.
Knowledge, Skills, Abilities, Training and Experience:
Excellent technical writing and oral communication skills required. Must be able to communicate effectively with both internal and external customers. A working knowledge of general analytical methodologies is required. A thorough understanding of basic organic chemistry is a plus. Knowledge of USP products and services highly desirable. Operates collaboratively at all levels of the organization in a highly technical environment. Working knowledge of relevant computer applications, especially MS Word and MS Excel are required. Experience with Oracle ERP preferred.
Frequent Contacts:
External vendors and suppliers
Reference Standards customers
Reference Standards Evaluation personnel
Laboratory staff
Reference Standards Expert Committee
Additional Information:
Exp: 1-5 years
Location: Hyderabad
Qualification: M.Sc, M.Pharm, Ph.D-chemistry
Functional Area: R&D
Industry: Pharma/Life sciences
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