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 III, Reference Standards Laboratory
Job Description
This is a non-supervisory position in Reference Standards Laboratory department, responsible for performing the required tests as per monograph/protocol for a given project, creating a complete report.
Roles and Responsibilities:
- Executing the analytical tests allotted by Project leader.
- Thorough knowledge of wet chemical analysis.
- Verification of the test protocols & giving test kit approvals, if required.
- Compilation of project reports and response to QA observations.
- Completing the projects as per the project timelines and priorities.
- Preparation and review of SOP’s.
- Ensuring the implementation of GLP, safety systems in the labs.
- Ensuring the calibration of the equipment’s as per the schedules.
- Indenting chemicals, column. Glassware, etc. and their procurement by coordination with lab operation and purchase department in advance keeping in mind the project deadlines.
- To ensure and follow USP mission, policies and procedures.
- To maintain good relationship with HR, Purchase, accounting, IT and other dept.
- Preparing, 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 in 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.
Required Skills
- Proficient with pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP, BP, EP, etc.).
- Expert in HPLC and GC and Wet Chemical analysis in API/Drug Substances and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, and thermal analysis techniques etc.).
- Knowledge of handling LCMS and GCMS will be added advantage.
- Proven track record of consistently delivering projects on time and with high quality.
- Takes personal responsibility for the delivery of projects to customers with ability to embrace and lead change.
- Excellent written and verbal communication skills.
Candidate Profile
Master's Degree in Organic Chemistry with minimum 5 to 7 years of relevant Industrial experience is required.
Additional Information:
Experience: 5 - 7 Years
Location: Hyderabad, Andhra Pradesh
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 15th June, 2017
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