Scientist II , CDL - Hyderabad / Secunderabad
- United States
- 4 - 6 years
- Hyderabad
- 4 years ago
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Job Description
- Literature search for the USP/NF projects.
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To ensure the projects requirements by coordinating with the Group Leader.
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To involve in project execution, method development and validation of USP/NF projects.
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To coordinate with Group Leader to complete the USP/NF projects within timelines.
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To ensure the knowledge on different drug products handling and samples preparations.
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To give training to the new joiner about USP/NF projects and provide support to junior staff.
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Ensure the project updates are provided to the supervisor on regularly
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Help for the team members to resolve technical challenges and criticalities.
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Complete the projects as per the time lines.
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Ensure that the calibrations of the equipment are performed as per the schedule.
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Coordinate with Group Leader for the procurement of samples, standards, chemicals, columns, glassware, etc. as per the need and availability.
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Prepare and review of relevant SOPs.
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Support and co-ordinate for completion of IQ/OQ/PQ for new instruments.
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Provide hands-on training to the new joiners and existing scientists.
- Plan and coordinate with Group leader for internal audits, ISO-9001, ISO17025 audits and related activities.
Basic Qualifications
- Master s Degree in Chemistry with 4-6 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 the 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 small molecules (drug substance, drug 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 4-6 years of experience or PhD with at least 2-4 years of experience in relevant field. Exceptional breadth of pharmaceutical industry 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 good understanding of GLP regulations and exposed to external regulatory audits.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area: IT Software - Application Programming, Maintenance, Role Category: Programming & DesignRole: Programming & DesignEmployement Type: Full timeEducation
Under Graduation: Any GraduatePost Graduation: Any PostgraduateDoctorate: Any DoctorateContact Details:
Company: United StatesLocation(s): Hyderabad
Keyskills: Uv Scientific Quality Assurance Hplc Technical Writing Method Development Gc - Ms Health Insurance
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