The U.S. Pharmacopeial Convention (USP) Scientist III ARD (Contract) in Hyderabad, India
Roles and Responsibilities
Support to reaction monitoring, scale up and final analysis of samples as per monograph / in-house procedures including method development if required.
Prepare development reports for Synthetic Support projects.
Involve in project acceptance & approvals.
Execute projects per the approved test protocols if assigned.
Responsible for preparation of SOPs, protocols, reports, etc.
Ensure the projects requirements by coordinating with the Purchasing department.
Responsible for preparation of the records and documents.
Ensure that the calibrations of the equipment’s are performed as per the schedule.
Prepare, execute, and complete IQ/OQ/PQ of new instruments.
Indent the required glass ware, chemicals, and columns for the ARD projects.
Maintain GLP & implement safety procedures while working in Lab.
Perform other Projects whenever free from ARD activities.
Perform other duties as assigned
Preparation and planning for ISO-9001 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.
Participates in USP cross-functional teams as appropriate
Sc. in Analytical Chemistry / Organic Chemistry, from a well-recognized University in India or abroad and required not less than 5-7 years’ experience or Ph.D. with 0-2 years of experience in Analytical lab.
Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, FTIR, UV-Visible, wet chemistry, etc.
Good technical writing and verbal communication skills are required. Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. Understanding of GMP Guidelines is a requirement
Proficient with pharmaceutical testing requirements involving compendial methods for reference materials.
Expert in HPLC and GC analysis 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 also have experience in hand held techniques like NIR and Raman spectroscopy.
Working knowledge of computer applications, such as MS Word and MS Excel are required.
Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.
Proven track record of consistently delivering projects on time and with high quality.
Prior experience in a high volume pharmaceutical ARD laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
Takes personal responsibility for delivery of projects to customers.
General chapter information Empower and NuGenesis will be preferred.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Note: As a condition of employment with United States Pharmacopeia- India Private Limited’s (USP), duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after November 1st, 2021 are required to be fully vaccinated unless a a reasonable accommodation is approved.
Job Category Contingent Staff
Job Type Full-Time