DifGen Pharmaceuticals

Research Associate

DifGen Pharmaceuticals  •  State of Telangāna, IN (Onsite)  •  3 months ago
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Job Description

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072
Job Shift: Day
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- - - - Responsible for execution of Analytical Method Development (Assay, Dissolution, Related substances, Adhesion testing, IVPT, etc.), Analytical method feasibility activities of drug substance / drug product / excipients.
- - - - Responsible for execution of activities related to Regulatory query and performing RLD analysis and COA generation.
- - - - Responsible for preparation of assessment report, Method Development report, Method Equivalency report of drug product.
- - - - Responsible for performing the qualification and calibration of analytical instruments like HPLC, IR and other standalone instruments (like water content, pH meter, Balances etc.,).
- - - - Responsible for preparation of protocols / reports / standard operating procedures and Standard Testing Procedures. Monitoring and supporting all method transfer related activities from ARD to the CMO locations.
- - - - Responsible for following cGLP/cGMP compliance of the Analytical Laboratory, ensuring laboratory safety, good laboratory practices, Good Documentation practice in the lab and general cleanliness and Training & development activities.
- - - - Responsible for to execute authorized to sign (as prepared and checked by) for, Certificate of analysis, Calibration record, Specification and Standard test procedure, Method Validation / transfer/Reverse Engineering / protocols and reports, Method equivalency report.
- - - - Responsible for any other work assigned by head of the department / designee as required.
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QualificationsM. pharmacy (chemistry/Analytical)
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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