Executive - Quality Assurance

Kores; Roha; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Kores in India requires a Quality Assurance/Quality Management professional to implement and maintain the QMS aligned with ISO 9001:2008, and ensure GMP compliance across production, warehouse and quality control functions.

The role includes reviewing management review decisions, monitoring quality objectives, approving quality documents, coordinating calibration, and planning recalls when needed to assure product safety and regulatory adherence.

Qualifications

• Knowledge of ISO 9001:2008 quality management systems.
• Understanding of GMP implementation and compliance.
• Experience in document control for SOPs, validation/qualification protocols and reports.
• Ability to review management review decisions and ensure corrective actions.

Responsibilities

• Implement and maintain QMS per ISO 9001:2008 across sites.
• Drive GMP implementation and ensure regulatory compliance.
• Review management review decisions and monitor quality objectives.
• Approve/authorize quality-related documents (SOPs,Protocols, Reports, Training, Calibration).
• Monitor work environment and initiate CAPA for production, warehousing and QC.
• Coordinate calibration procedures and ensure traceability to national standards.
• Plan and coordinate during product recalls if necessary.
• Release or reject APIs and intermediates for distribution.
• Establish systems to release or reject raw materials, intermediates, packaging and labeling.
• Review batch production and QC records before API release.
• Investigate and resolve critical deviations.
• Approve procedures impacting quality of intermediates or APIs.

Job description

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