U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Scientist II - ARD in Hyderabad, India

Description

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.

  • Complete ARD- (USP-NF, CDL and PAI) projects within timelines by coordinating with Manager.

  • 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.

  • Participates in USP cross-functional teams as appropriate

Basic Qualifications

  • Sc. in Analytical Chemistry / Organic Chemistry, from a well-recognized University in India or abroad and required not less than 4 years’ 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 / ISO-9001 Guidelines is a requirement

Preferred Qualifications

  • Proficient with pharmaceutical testing requirements involving compendial methods for reference materials.

  • Handling of HPLC and GC instruments 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.

  • 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.

Supervisory Responsibilities

None

Job Category Chemistry & Scientific Standards

Job Type Full-Time

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