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Post : Scientist III, RSE
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).
This incumbent is responsible for the timely preparation of bulk 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/replacement 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 have discussion with Scientific Liaison’s (SL’s) and Expert Committee (EC) members during new monograph or monograph modernization processes. Participating in peer review of draft monograph before submission to Pubs.
• To Draft product planning documents (PPD), coordinates with labs, and reviews/interprets data from international collaborative studies.
• Submits collaborative study summary reports to review and subsequent approval for each RS lot. Addresses the concerns of balloters to achieve successful approval of RSCEPs.
• To have ability to do “Problem solving” at any step of RS development process.
• To produce quality documents (RSCEP, Addenda, TP) with minimum comments from RSTO and no “Major” observation from QA.
• 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.
• Performs and participate in other related duties as assigned.
Candidate Profile
Basic Qualifications
• Preferably Ph.D. in Chemistry with 5-7 years of Research/Industrial experience
• MSc./M Pharm from a recognized University with 7-8 years of Industrial experience.
• Thorough knowledge in pharmaceutical analysis with data interpretation would be an added advantage.
Preferred Qualifications
• Ability to read and interpret spectroscopic analyses data (NMR, IR, MS)
• Ability to handle multiple priorities in a fast-paced environment.
• Excellent written and verbal communications skills.
Additional Information
Experience : 5-7 years
Qualification : Ph.D, M.Pharm, M.Sc
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : RSE
End Date : 25th September, 2021
