The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post: Scientist II, Reference Standards Laboratory
Job Description
This is a non-supervisory position in Reference Standard Laboratory responsible for performing the required tests as a part of the project and maintaining the GLP environment in the Laboratory.
Job Responsibilities:
• Executing the analytical tests allotted by Project or Group Leader.
• Verification of test protocol and giving test kit approvals, if required.
• Supporting Verification, GPH, PQM and other departmental teams in terms of testing and project review whenever needed.
• Responsible for preparation of project evaluation reports.
• Responsible for sample tracking and chemical inventory tracking in the laboratory.
• Coordination with group leader to ensure completion of the projects allotted to the team.
• Initial review of the project reports and documents and assisting the group leader when required.
• Completing the project as per the timelines and trouble shoot the scientific aspects of the projects on need basis.
• Responsible for preparation and review of SOP’s protocols, reports etc.
• Responsible for performing the calibration of the equipment’s as per the schedule.
• Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.
• Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
• Taking up any additional responsibilities assigned by group leader from time to time.
• Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.
Required Skills
• Proficient with pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP, FCC, NF, etc.).
• Expert in Chromatographic analysis, especially in HPLC and troubleshooting, proficient in other related analytical instrumentation (Titrations, IR, KF, UV, Thermal, Elemental analysis etc.),
• Proven track record of consistently delivering projects on time and with high quality.
• Having knowledge of Empower software, ELN, ERP, QR coding system are added advantages.
• Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.
• Takes personal responsibility for delivery of projects to customers.
• Ability to embrace and lead change. Extremely adaptable. Excellent communication skills, both written and verbal.
Required Experience
Ph.D. in Chemistry with 1-2 years or Master degree in Chemistry with 3-5 years of relevant laboratory experience.
Additional Information:
Experience: 3-5 years
Location: Hyderabad, Andhra Pradesh
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Last date: 30th August, 2017
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