Executive - Quality Assurance

1) Implementation of quality management system in accordance with ISO 9001:2008.

2) Responsible for GMP implementation & compliance.

3) Review and implementation of the decisions taken in the management review meeting.

4) To monitor and achieve the objectives of quality policy.

5) Review and approve/authorize all quality related documents (viz. SOPs Validation Protocols and reports, Qualification Protocols and Reports, Training, Calibration and Maintenance schedules, Departmental Manuals, System procedures).

6) Monitoring of the work environment related to processes in the production, warehouse and quality control and suitable correction, corrective and preventive actions.

7) Planning, control and review of systems and procedures for calibration and ensuring calibrations are completed traceable to the national or equivalent standards and take corrective actions in the event of calibration failures or doubts on the performance of the calibrated instruments or when found out of calibration limits.

8) To plan and coordinate during product recall if any for any reasons.

9) Releasing or rejecting all APIs. Releasing or rejecting intermediates for use outside the control of the manufacturing company;

10) Establishing a system to release or reject raw materials, intermediates, packaging and labelling materials;

11) Reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution;

12) Making sure that critical deviations are investigated and resolved;

13) Approving all specifications and master production instructions;

Approving all procedures impacting the quality of intermediates or APIs; Role & responsibilities

Preferred candidate profile