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 Manager: Reference Standards Evaluation
Job Description
Summary of the Position:
This is a hands-on 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 all 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:
This is a Supervisory position in Reference standard Evaluation department, responsible for the successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS) of the team.
* To guide the team members in reference standard evaluation process and give technical assistances.
* To coordinate with RSE-Rockville to ensure completion of the assigned RS Portfolio’s as per the timelines.
* Responsible for timely preparation of procurement specifications and collaborative testing protocols for new RS lots, technical assistance for collaborating labs
* 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.
* Drafts planning documents, coordinates with labs, and reviews/interprets data from multi-laboratory studies
* To submit collaborative study summary reports to RSE Rockville and subsequent approval for each RS lot.
* To address all the queries raised by the balloters to achieve successful approval of RSCEPs.
* To coordinates for any additional necessary testing and assists other staff members in addressing the comments.
* To oversee and support the CSU programs and India synthetic lab projects as per new ISO 17025 process for the replacement lots
* 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
* 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.
* To initiate the improvements in the RSE process and to develop and Presents technical issues/presentations to inter-departmental USP staff. To facilitate additional cross-functional activities with other departmental staff and other USP staff.
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Required Skills:
- Excellent technical writing and oral communication skills required.
- A working knowledge of general analytical methodologies (HPLC, GC, TLC, UV, NMR, IR, MS, wet chemistry, and cGMP/GLP) required, and a thorough understanding of basic organic chemistry a plus.
- Knowledge of USP reference standards and testing methods or pharmaceutical industry in-house reference standards qualification highly desirable.
- Experience in Characterization of analytical data using NMR,MASS,IR techniques would be an added advantage.
- Working knowledge of relevant computer applications, especially Microsoft Word, Excel and Oracle ERP, required.
Required Experience :
Ph.D. Or MSc degree in Chemistry or Pharmacy, with 10 -12 years of relevant experience in pharmaceutical analysis, including laboratory experience in compendial methods and administrative experience related to USP programs.
Additional Information:
Experience: 10-12 years
Tracking Code: 614-679
Location: Hyderabad, Andhra Pradesh, India
Education: Ph.D/ M.sc in pharmacy
Industry Type: Pharma/ Healthcare/ Clinical research
End Date: 15th June, 2016
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