Role: Team Member - DQA (Development QA)

Experience: 5 to 10 years

Qualification: Masters

Must have skills:

Must have Experience in Quality Assurance with API R&D; / NCE CDMO labs facility.

Previous stint in analytical development for NCE / API will be added advantage.

To ensure Compliance with Corporate Policies (Quality Safety COBE etc.)

To ensure respective Standard Operating Procedures to be followed during the development of the molecules.

Preparation review approval control and revision of standard operating procedures.

Preparation review approval control and revision of Site Mater File Quality agreements.

Documentation control (Issuance Retrieval Supersede Obsolete and Destruction)

Investigation Implementation Approval and Compliance of Quality Systems (Change Controls Incidents OOS and CAPA)

Coordinate with the plant team to investigate complaints stability OOS and manufacturing incidents.

Review and Approval of Calibration and Preventive Maintenance Schedule and to ensure the activity carried out as per the schedule

Review and Approval of Qualification Protocols and Reports (Facility Utility Equipment)

Review of Experiments in Electronic Lab Notebook (ELN)

Review Approval and distribution of Analytical Method Validation protocols Reports Specification & Method of analysis cleaning validations Method summary reports etc.





To perform Quality Risk Assessment and QbD as per Customer Requirement

Supporting regulatory affairs team for ANDA/NDA filling and regulatory deficiency closure

Planning and Execution of activities related to Development Quality Assurance.

Qualification and Compliance of External Manufacturing Facilities (SBP).

Participate in Customer Teleconferences and respond to the Customer queries.

Review presentations and presenting quality issues through Quality Management Review.

Review approval distribution of development documents like Feasibility report Optimization report Familiarization report FMEA report QBD report.

Allot the project code for the recent project allot technical numbers & document numbers to AR&D; and R&D.;

Conduct gate meeting and facilitate the technology transfer between development and absorption team.

Handling of technology transfer queries and arranging technology transfer documents by coordinating with the concerned departments.

Review of Master Batch Production records change notifications received from SBPs and approve issue in timely manner.

Tracking of customer audit reports and responses.

Any other responsibilities assigned by the group leader/head of the department

Interested candidates with relevant experience may share profiles to

📌 Team Member DQA (Hyderabad)
🏢 Aurigene Pharmaceutical Services
📍 Hyderabad