Senior Executive

DIFGEN PHARMACEUTICALS PRIVATE LIMITED; Hyderabad; Sur place; INR 800 000 - 1 100 000; Plein temps

Résumé du poste

DIFGEN PHARMACEUTICALS PRIVATE LIMITED in Hyderabad is seeking an experienced M Pharmacy professional for Development Quality Assurance. The role focuses on preparation, review and approval of Specifications, SOPs, FRD and DQA documents, as well as deviation and change control activities.

You will ensure cGLP/cGMP compliance, maintain calibration records, and support internal audits in a GMP laboratory environment.

Qualifications

• M Pharmacy with 5-7 years of experience in Development Quality Assurance.
• Experience in preparation/review/approval of Specifications, SOPs, FRD and DQA documents.
• Knowledge of cGLP/cGMP compliance and calibration activities.
• Experience in investigations and regulatory/quality notifications.
• Strong documentation practices and cross-functional coordination.

Responsabilités

• Prepare, review and approve Specifications and Test Procedures for finished products and APIs.
• Prepare/review ARD, FRD, and DQA related SOPs and sign-off.
• Manage allotment of CCF numbering, change control assessment and closure.
• Oversee deviations, instrument IDs, logbooks and training records as DQA.
• Support internal audits and risk assessment reporting.

Connaissances

Quality Assurance

Documentation

Internal audits

Investigation & CAPA

cGLP/cGMP compliance

Formation

M Pharmacy

Outils

SOP management

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