About this role
- 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