Scientist III, Analytical Research
- United States
- 8 - 13 years
- Hyderabad
- 5 years ago
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Job Description
Roles and Responsibilities
- Prepare for execute the Synthetic R D and collaborative testing projects as per ISO/IEC 17025.
- Ensure the projects requirements by Coordinating with the supervisor
- Ensure the availability of chemicals, standards and test licenses.
- 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 collaborative testing 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 ISO 17025 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
Required Skills
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Proficient with pharmaceutical testing requirements involving compendial methods for reference materials.
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Expert in HPLC and GC analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, and thermal analysis techniques etc.).
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Knowledge of handling LCMS and GCMS will be added advantage.
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Working knowledge of computer applications, such as MS Word and MS Excel are required.
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Good interpersonal skills and proven ability to function in a team oriented environment are necessary.
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Proven track record of consistently delivering projects on time and with high quality.
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Prior experience in a high volume pharmaceutical ARD laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
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Takes personal responsibility for delivery of projects to customers.
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General chapter information, Empower and NuGenesis will be preferred.
Required Experience
- M.Sc. in Analytical Chemistry / Organic Chemistry, from a well recognized University in India or abroad and required not less than 6 8 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.
- Must have experience with electronic notebook documentation of experimental procedures (LMS) and QMS system.
- 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 IEC 17025 Guidelines is a requirement
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: MS/M.Sc(Science) in ChemistryContact Details:
Company: United StatesLocation(s): Hyderabad
Keyskills: Organic chemistry Scientist III Technical writing Pharma Instrumentation GLP Thermal analysis GMP Troubleshooting HPLC
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