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 Compendial Development Laboratory
Job Description
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.
• 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.
• Work professionally and collaboratively with fellow lab scientists, scientific liaisons, and other relevant departments in the review and development of documentary standards.
• 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.
• Track day-to-day activities and workload, and provide updates and weekly report to the Manager.
• Assist in quality audits as necessary.
Candidate Profile
• Minimum Master’s Degree in Chemistry or pharmaceutical sciences with 3-5 years, having hands on experience in the field of analytical testing and method development of pharmaceutical substances and finished products.
• Should possess a fair understanding of USP’s monographs/general chapters/general notices.
• Should have 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.
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Required Experience
• 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, GC, FTIR, UV-Visible.
• Should have good understanding of GLP regulations.
• 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.
Additional Information:
Experience: 1-3 years
Job ID : 1055-679
Location: Hyderabad, Andhra Pradesh
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Compendial Development Laboratory
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