Senior Scientist - Hyderabad / Secunderabad
- United States
- 7 - 10 years
- Hyderabad
- 5 years ago
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Job Description
Description
Coordinate with supervisor to maintain the Lab as per GLP and safety practices.
Search literature for the USP/NF/OTC/DSC/FCC/Excipient projects.
To ensure the projects requirements by coordinating with the Group Leader.
To involve in project execution, method development and validation of USP/NF/DSC/FCC/OTC projects.
To coordinate with Group Leader to complete the USP/NF/DSC/FCC/OTC projects within timelines.
Assist Group Leader as deputy for preparations of project reports and compilation of data.
To give training to the new joiner about USP/NF/DSC/FCC/OTC projects and provide support to junior staff.
Review the project plans, reports, Laboratory notebook/ Electronic laboratory notebook and compiled related project data.
Monitor the projects steps such as inward, under process, archival, disposal, etc. and review the records.
Mentor for the team members to resolve technical challenges and criticalities.
Complete the projects as per the time lines.
Ensure that the calibrations of the equipment are performed as per the schedule.
Coordinate with Group Leader for the procurement of samples, standards, chemicals, columns, glassware, etc. as per the need and availability.
Prepare and review of relevant SOPs.
Support and coordinate for completion of IQ/OQ/PQ for new instruments.
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.
Support the Group leader to respond the QA observations on time.
Basic Qualifications
- Master s Degree in Chemistry with 7-10 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 7-10 years of experience or PhD with at least 3-5 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: Pharma, Biotech, Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology, Role Category: R&DRole: R&DEmployement Type: Full timeEducation
Under Graduation: Any Graduate in Any SpecializationPost Graduation: Any Postgraduate in Any SpecializationDoctorate: Any Doctorate in Any SpecializationContact Details:
Company: United StatesLocation(s): Hyderabad
Keyskills: Procurement Analytical skills Chemistry Manager Quality Assurance Technical writing FTIR GLP GMP HPLC OTC
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