Scientist II - CHM - Hyderabad / Secunderabad
- United States
- 3 - 5 years
- Hyderabad
- 3 years ago
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Job Description
Job description
Summary of the Position
- This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations.
- The incumbent will be responsible for performing USP/NF/FCC method development and method validation projects and maintaining safety and GLP environment in the lab.
- This position is a component of USP s core business, and the incumbent is expected to support monograph modernization initiatives.
Roles and Responsibilities
- Literature search for the USP/NF/FCC projects.
- To ensure the projects requirements by coordinating with the Group Leader.
- To involve in project execution, method development, and validation of USP/ NF/FCC projects.
- To ensure the knowledge on different drug product handling and sample preparations.
- Provided effective technical and scientific expertise regarding drug substance and drug product analytical development
- Engage in project planning, execution, method development, and validation of projects according to set standards as USP general chapters, guidelines, SOPs, and protocols.
- Ensure the project updates are provided to the supervisor regularly.
- To coordinate with Group Leader to complete the USP/ NF/FCC projects within timelines.
- Responsible for preparation and review of SOPs, protocols, reports, etc.
- Responsible for the review of the records and documents.
- To ensure that the calibrations of the equipment are performed as per the schedule.
- Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
- To indent the required glassware, chemicals, and columns for the USP/NF/FCC projects.
- To maintain GLP safety procedures while working in Lab.
Basic Qualifications
- Master s Degree in Chemistry with 3-5 years of experience.
- Possess a fine understanding of USP/NF/FCC monographs/general chapters/general notices.
- Exposure to GMP/GLP/QMS environment and documentation procedures and champions data integrity.
- Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
- Good analytical skills in handling method development and Validations for Food ingredients and food products. Should have exposure to GMP/GLP environment and documentation procedures.
- Awareness of ISO/IEC 17025 is desirable.
Preferred Qualifications
- Master s Degree in Chemistry (Analytical / Organic) or Pharmaceutical Sciences with 3-5 years of 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, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible.
- Should have a fair understanding of GLP regulations and exposed to external regulatory audits.
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: R&D
Role: R&D
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Any Postgraduate in Any Specialization
Doctorate: Doctorate Not Required
Contact Details:
Company: United StatesLocation(s): Hyderabad
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Keyskills: Analytical skills Chemical analysis Method validation Technical writing Pharma FTIR Project planning GLP GMP HPLC
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