Senior Executive

Aveva Drug Delivery Systems; Hyderabad; On-site; INR 500,000 - 850,000; Full time

Job summary

Aveva Drug Delivery Systems in Hyderabad is seeking a Development Quality Assurance professional with an M Pharmacy and 5-7 years of QA experience. The role focuses on ensuring compliance and robust documentation across finished products and APIs in OSD and injectables.

You will prepare and review ARD/FRD/DQA SOPs, manage change control, calibration, internal audits, and risk assessments, while upholding cGLP/cGMP standards and ensuring document effectiveness.

Qualifications

• M Pharmacy degree with 5-7 years experience in Development Quality Assurance.

Responsibilities

• Prepare/review/approve specifications, SOPs and test methods for finished products and APIs.
• Prepare/review ARD, FRD and DQA related SOPs and sign-off.
• Manage CCF numbering allotment, change control assessment and CCF closure.
• Handle deviations related to Unit-I.
• Allocate instrument/equipment IDs and SOP numbers.
• Prepare/review/approve ARD, FRD and DQA related SOPs and sign-off.
• Issue formats, logbooks and training records as DQA and ensure document effectiveness.
• Review calibration activities and other cGLP/cGMP activities if required.
• Internal audit related activity as Quality Assurance.
• Prepare risk assessment and justification reports.
• Investigate/record raised notifications during lab activities.
• Follow cGLP/cGMP in the Laboratory and maintain Document cell.
• Follow good documentation practice and maintain lab cleanliness.
• Any other work assigned by head of department.

Education

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

Job description

Job Details

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.

Responsibilities

• 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