DifGen Pharmaceuticals

Senior Research Associate

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  5 months ago
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Job Description

Job Location Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072 Job Shift Day

  • Responsible for execution of Analytical Method Transfer / Analytical Method Validation / Analytical Method verification / Analytical method feasibility activities / other activities for drug substance / drug product / excipients.
  • Responsible for qualification/ maintenance/ handling of working standards/ reference standards and impurities.
  • Responsible for performing RLD analysis and COA generation.
  • Responsible for preparation of risk assessment report of Nitrosamine / Elemental impurities / Residual Solvents.
  • Responsible for performing the qualification and calibration of analytical instruments like HPLC, UV-Vis spectrophotometer, IR and other standalone instruments (like water content, pH meter, Balances etc.,).
  • Responsible for preparation/ review / approval of protocols / reports / standard operating procedures.
  • Responsible for performing investigation / reporting of the raised notification during AMV activities.
  • Responsible for review of the change controls.
  • Responsible for following cGLP/cGMP compliance in the AMV Laboratory and maintenance of Document cell.
  • Responsible for following good documentation practice and general cleanliness in the AMV laboratory.



Qualifications

Mpharm or MSc

DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
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