Senior Executive

DifGen Pharmaceuticals LLC; Telangana; Sur place; INR 800 000 - 1 200 000; Plein temps

Résumé du poste

DifGen Pharmaceuticals LLC in Telangana seeks a professional with an M Pharmacy and 5–7 years of experience to join our Development Quality Assurance team.

The role centers on preparing, reviewing, and approving specifications, SOPs, and test methods for finished products and APIs, ensuring strong documentation and strict cGLP/cGMP compliance.

Qualifications

• M Pharmacy with 5-7 years of experience in development QA.

Responsabilités

• Prepare/review/approve specifications, SOPs, and test methods for finished products and APIs.
• Coordinate ARD/FRD/DQA SOP sign-off and related activities.
• Review calibration and other cGLP/cGMP activities as needed.

Connaissances

Quality Assurance

Documentation

cGLP/cGMP

Formation

M Pharmacy

Description du poste

• 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.

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