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: Scientist- II, Verification Programs
Job Description:
This is a non-supervisory position in Verification Programs department, responsible for performing the required tests as a part of the projects and maintaining GLP environment in the lab.
Roles and Responsibilities:
- Execute the analytical tests allotted by team leader.
- Complete the projects as per the project timelines and priorities.
- Compilation of project reports and response to QA observations.
- Ensure the implementation of GLP, safety systems in the labs.
- Ensure the calibration of the equipment’s as per the schedules.
- Indent chemicals, column, Glass ware and other project requirements and their procurement by coordination with lab operation and purchase department in advance keeping in mind the project deadlines.
- Ensure and follow USP mission, policies and procedures.
- Maintain good relationship with RSL, PQM, Lab Operations and other departments.
- Preparation, executing and completing IQ/OQ/PQ of new instruments.
- Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues on a timely manner.
- Taking up any other additional responsibilities assigned by supervisor on a proactive basis and allotting additional responsibilities to the reporting staff in consultation with the supervisor.
Candidate Profile:
Master’s Degree in Chemistry or pharmaceutical sciences with 3-5 years hands on experience in the field of analytical testing of pharmaceutical substances, finished products and Dietary Supplements.
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Knowledge, Skills, Abilities:
Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, ICP, FTIR, UV-Visible, etc. Familiarity with and exposure to external regulatory audits required. Must be able to communicate effectively with customers. Working knowledge of computer applications, such as MS Word and MS Excel and exposure to lab software’s such as e-LNB, NuGenesis, and Empower would be advantageous. Prior experience of API and Dietary supplements analysis in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
Frequent contacts:
All laboratory staff, Quality Assurance and Internal USP employees
Additional Information:
Experience: Min. 3 Years
Location: Hyderabad
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Other
End Date: 15th January, 2015
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