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.
Post : Senior Scientist I/ Scientist III - Reference Standards Evaluation
Job Description
This is a Non-supervisory position in Reference Standard Evaluation department, responsible for oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS).It is more of an operational and tactical role. This incumbent is responsible for the timely preparation of procurement specification and collaborative testing protocols for all RS lots, technical assistance for collaborating labs, analytical data review and preparation of summary reports, preparation of packaging and Quality Control testing instructions.
Roles and Responsibilities:
- Responsible for timely preparation of procurement specifications and collaborative testing protocols for new RS lots, technical assistance for collaborating labs
- To review the analytical data received from the Collaborators and to prepare summary reports and RSCEP packages, preparation of packaging and QC testing instructions and assigning periodic re-test intervals. Independently maintains successful scheduling operations, necessary documents, complete and accurate information; and addresses quality issues to ensure availability of reference standards in a complex portfolio.
- To Draft product planning documents (PPD), coordinates with labs, and reviews/interprets data from international collaborative studies.
- Submits collaborative study summary reports to peer review and subsequent approval for each RS lot. Addresses the concerns of balloters to achieve successful approval of RSCEPs.
- To Coordinates for any additional necessary testing and assists other staff members in addressing the comments.
- To provide correct guidance on the interpretation of test data, Proposes and designs studies to obtain necessary data to resolve complaints.
- To demonstrate technical understanding to internal and external audiences regarding USP's Reference Standards program.
- Engages in conversation about reference standards issues. Addresses general customer technical inquiries and thoroughly investigates customer complaints with minimal guidance.
- Presents information to USP staff and external audiences.
- Facilitates additional cross-functional activities with other departmental staff and other USP staff.
- Performs other related duties as assigned.
Candidate Profile
Ph.D in Chemistry from a recognized University. Post Doctorates from Reputed University and relevant research experience can also be considered.
Minimum of 5 years of Pharmaceutical industry experience
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Required Experience
Ability to handle multiple priorities in a fast-paced environment.
Knowledge in interpreting Characterization data’s like NMR.Mass, IR etc…
Thorough knowledge in interpretation and technical review of analytical data
Excellent written and verbal communications skills.
Ability to interact with Experts, scientists and customer queries in both technical and non-technical discussions.
Additional Information:
Experience: 5 years
Tracking Code: 984-679
Location: Hyderabad, Andhra Pradesh, India
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 30th November, 2017
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