DifGen Pharmaceuticals

Senior Executive

DifGen Pharmaceuticals  •  ₹500k - ₹850k/yr  •  State of Telangāna, IN (Onsite)  •  2 hours ago
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Job Description

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072,

Position Type: Full Time,

Salary Range: ₹500,000.00 - ₹850,000.00 Salary/year,

Job Shift: Day,

  • Responsible for preparation/ review/ approval of Specification, Standard Test Procedure, Test Method of Finished products and API of various product of OSD as well as Injectables based upon the priority and allotment of document numbering.
  • Responsible for preparation/ review of all ARD, FRD and DQA related SOP and their sign off activity.
  • Responsible for taking care of Allotment of CCF Numbering, Change Control Assessment and CCF closer activity.
  • Responsible for taking care of Deviations related activity of Unit-I.
  • Responsible for allotment of Instrument / Equipment ID and their SOP Number.
  • Responsible for preparation/ review/ approval of all ARD, FRD and DQA related SOP and there sign off activity.
  • Responsible for taking care of all the issuance of formats, logbook and training record as DQA Person to all other departments and making Documents Effective.
  • Responsible for Review of calibration activities and other cGLP/ cGMP activity if required.
  • Responsible for Internal audit related activity as Quality Assurance.
  • Responsible for preparation of risk assessment reports and justification reports.
  • Responsible for performing investigation / reporting of the raised notification during any lab related activities.
  • Responsible for following cGLP/cGMP compliance in the Laboratory and maintenance of Document cell.
  • Responsible for following good documentation practice and general cleanliness in the laboratory.
  • Responsible for any other work assigned by head of the department / designee as on when required.

Qualifications: M Pharmacy with 5 - 7 Years of experience in Development Quality Assurance

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
Pharmaceutical & Medicine
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
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