Function of the Position:
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.
This is a hands-on non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for the development and validation of the documents standards using multiple source ingredients and products while maintaining GLP and safe practices. This position is a component of USP’s core business and the incumbent is expected to support monograph modernization initiatives.
Roles and Responsibilities:
- Perform literature search, plan and execute compendial projects as per protocols, guidelines and established SOPs. The incumbent will be responsible for ensuring the development of modern, rugged and transferable methods.
- Ensure the projects requirements are met by coordinating with the supervisor and respective scientific liaisons by proving input to run the activities.
- Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
- Monitor each stage of development closely and coordinate with supervisor to complete the projects within time.
- Responsible for preparation and review of SOPs, Protocols, reports etc.
- Responsible for review of the records and documents and archival of projects records. In addition, get involve into peer review system and provide unbiased feedback on data and reports.
- Ensure that the calibrations of the equipment are performed as per the schedule and take part in preparation, execution and completion of IQ/OQ/PQ for new instruments.
- Indent the required glass ware, chemicals and columns for the projects and support lab ERP coordinator to maintain the inventory of chemicals and LC columns.
- Work professionally and collaboratively with fellow lab scientists, scientific liaisons, and other relevant departments in the review and development of documentary standards.
- Identify and implement solutions to technical problems related to the development and analysis of the data.
- Implement and maintain key quality systems such as deviations, investigations, and CAPA’s Maintain GLP & safety procedures while working in Lab, in addition to ISO 9001 – ISO/IEC 17025 requirements.
- Tracks day-to-day activities and workload, and provides updates and weekly report to the Manager.
- Develops and reviews SOP’s, Operation Manuals, and training documents.
- Assists in quality audits as necessary.
Knowledge, Skills and Abilities:
Excellent technical writing and oral communication skills required. Must be able to communicate effectively with diplomacy and enthusiasm. Technical and analytical skills required including the ability to interpret technical information. Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible. Having hands on experience on LC-MS is preferable. Should have fair understanding of GLP regulations and exposed to external regulatory audits. Working knowledge of computer applications, such as MS Word and MS Excel and exposure to lab software such as e-LNB, NuGenesis, Autochrome, Zenith, and Empower would be advantageous.
ARD Laboratory Staff, Scientific liaisons, Stores, QA Manager, Lab operations and Procurement section.
Education and Experience:
Master’s Degree in Chemistry or pharmaceutical sciences with 3-5 (or 1-2 with PhD) years, having hands on experience in the field of analytical testing and method development of pharmaceutical substances and finished products. Possess a fair understanding of USP’s monographs/general chapters/general notices. Exposure to GMP/GLP/QMS environment and documentation procedures. Should be capable of doing Analytical method developments and method validations using modern techniques and protocols.
Job LocationHyderabad, Andhra Pradesh, IndiaPosition TypeFull-Time/Regular