Executive

DifGen Pharmaceuticals LLC; Telangana; On-site; INR 300,000 - 500,000; Full time

Job summary

DifGen Pharmaceuticals LLC is seeking a M. Pharmacy graduate with up to 4 years of experience to handle documentation and compliance in the quality/lab environment. The role involves assigning IDs, preparing SOPs, maintaining stability chambers, and managing RLD samples and logbooks.

You will also oversee the numbering of specifications and test procedures for finished products and APIs, ensure training for new joiners, and maintain accurate documentation and logbooks across departments.

Qualifications

• M.Pharmacy degree required for the role.
• Experience expectation: less than 4 years in the relevant lab/quality documentation environment.

Responsibilities

• Assign Instrument / Equipment IDs and their SOP numbers.
• Prepare/review ARD, FRD and DQA related SOPs and sign-off activities.
• Maintain Stability Chamber maintenance.
• Issue and maintain RLD samples and RLD logbooks.
• Allot numbering for Specifications, SOPs, test methods for finished products and APIs across OSD and Injectables; track change control numbers and IDs.
• Provide SOPs for new joiners, induction and training activities.
• Manage formats and logbooks across departments, including training records and ARD/FRD/PRD logs.
• Handle Documentation Cell activities: filing master copies, CCFs, and alphabetic filing; overall Documentation Cell maintenance.
• Ensure cGLP/cGMP compliance in the laboratory and maintenance of the Documentation Cell.
• Follow good documentation practice and maintain laboratory cleanliness.
• Perform other duties as assigned by head of department as required.

Education

M. Pharmacy

Job description

• Responsible for assigning of Instrument / Equipment ID and their SOP Number.
• Responsible for preparation/ review of all ARD, FRD and DQA related SOP and their sign off activity.
• Responsible for Maintenance the Stability Chamber Maintenance.
• Responsible for RLD samples issuance and maintenance of RLD logbooks.
• Responsible for Allotment of Numbering of Specification, Standard Test Procedure, Test Method of Finished products and API of various product of OSD as well as Injectables, change control number, Instrument / Equipment ID and their SOP Number.
• Responsible for providing SOP’s for new joiners, Induction and Training related Activity.
• Responsible for All the Formats and Logbook issuance related Activity of All Departments along with Employee training record Lab Not book issuance for ARD, FRD and PRD.
• Responsible for Documentation Cell related Activity like Filing of the Master copy, CCF’s in Files, Numbering all the Files and keeping them in Documentation cell alphabet wise. (Over all Maintenance of Documentation Cell)
• 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 less than 4 years of experience.