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.
Post : Senior Scientist I, Verification Program
Job Description
This is a key hands-on, non-supervisory position. In this role, the Scientist performs the required analytical tests of Verification samples using appropriate methods. The Scientist will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical support and knowledge. The Scientist has mastered many common techniques in the laboratory and is able to contribute their own observations and input to difficult projects. The incumbent will provide technical assistance to the Verification Program by performing analytical tests, reviewing analytical data and preparing summary reports. The incumbent may execute 80% - 100% of their work at the bench level.
Roles and Responsibilities:
- Executes the Verification projects by performing an individual analytical tests allotted by the Group Leader.
- Completes the projects as per the project timelines and priorities.
- Demonstrates solid scientific approach to analysis in the laboratory.
- Routinely applies personal experience, academic training, and technical insights – including emerging sciences – to solve complex technical problems within the laboratory.
- Presents technical seminars and lab demonstrations.
- Compiles project reports and responds QA observations.
- Executes all testing and analysis of data with excellence and essentially no errors;
- Demonstrates a strong desire to continue learning and grow personal capability;
- Pursues, recommends, and implements new approaches or processes to improve laboratory operations;
- Positively influences project direction by ensuring own work is congruent with overall direction of laboratory projects;
- Assists with other testing programs and housekeeping duties in the laboratory as needed.
- Prepares and reviews SOPs.
- Ensures the implementation of GLP, safety systems in labs.
- Ensures the calibration of the equipment as per the schedule.
- Indents chemicals, columns, Glassware, etc. and procures them by coordinating with lab operations and purchase department in advance keeping in mind the project deadlines.
- Ensures and follows USP mission, policies and procedures.
- Maintains good relationship with QA, HR, Purchase, accounting, IT and other dept.
- Preparation and planning for ISO-9001 & ISO- 17025 certification / recertification by participating actively and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
- Supports collaborative testing, GPH, RSL and other departmental teams in terms of project testing, review, execution and approval whenever needed
Required Skills
• Experience in a cGLP/cGMP environment and qualification/validation of analytical methods is desirable.
• Good understanding of basic concepts in chromatography, as well as other general analytical chemistry principles.
• In addition, candidate should have practical knowledge and experience in Quality systems.
• The candidate must take personal responsibility to ensure work is delivered on time and is of the highest possible quality.
• Ability to anticipate, trouble shoot, and solve technical problems in their purview. Strong communication and presentation skills, both verbal and written are preferred.
Candidate Profile
• Ph.D. with minimum 5 to 7 years of relevant laboratory experience or Masters with 7 to 9 years of relevant laboratory experience.
• Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical testing laboratory
• Ability to lead projects to completion with a high degree of scientific expertise. Proficient with pharmaceutical testing requirements and test protocols involving compendial methods (USP, BP, EP, etc.). Expert in ICP, HPLC, GC, Dissolution analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, etc), strong communication and presentation skills, both verbal and written, experience working in the pharmaceutical industry strongly preferred. Should have very good skills to present the technical seminars and should participate in lab demonstrations. Knowledge of DEA, ICH guidelines and FDA regulations, and experience with compendial procedures and compliance strongly preferred. Proficiency with electronic documentation systems strongly preferred. Takes personal responsibility to ensure work is delivered on time and is the highest possible quality. Skills to anticipate, troubleshoot, and solve technical problems.
Additional Information
Experience : 5 - 7 years
Qualification : Ph.D, M.Sc, M.Pharm
Location : Hyderabad, Andhra Pradesh
Industry Type : Pharma
Functional Area : R&D
End Date : 21st November, 2018
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