Executive QA (APQR)

S Kant Healthcare; Vapi; Presencial; INR 350.000 - 550.000; Jornada completa

Descripción de la vacante

S Kant Healthcare in Gujarat is seeking a quality assurance professional to manage the Change Control Programme, deviations, and the preparation and review of Product Quality Reviews and QMS documentation.

The role includes issuing SOPs, maintaining logbooks, reviewing BMR/BPR, ensuring cGMP compliance, data integrity, and CAPA processes, with reporting to the Head QA and Deputy Manager and involvement in SQE activities.

Responsabilidades

• 01 Handling the Change Control Programme and functional Change Control Coordinator.
• 02 Handling of Deviation and Market Compliant.
• 03 Preparation and review of Product Quality Review.
• 04 Preparation, maintenance, review of all other QMS documentation.
• 05 Preparation and issuance of SOP's.
• 06 To maintain logbook and document control.
• 07 Issuance of format.
• 08 Reviewing of BMR / BPR.
• 09 Ensure the implementation and compliance with cGMP aspects.
• 10 Ensure compliance with Data Integrity.
• 11 Administrative Reporting to Head QA.
• 12 Functional Reporting to Deputy Manager.
• 13 Investigation in case of Incident, Market complaint, Product Recall, Out of Specification or any other factor that may affect product quality.
• 14 Implementation of Corrective Action and Preventive Action.
• 15 To participate in the SQE meeting, ensure the implementation of quality culture on the shop floor, and update the core committee on the progress of the SQE.
• 16 To review new legislation and guidelines (For WHO, EU, ICH, Others) & evaluate the need for any system updation and or resources requirement.
• 17 Preparation, Compilation and Review of CPV.

Descripción del empleo

Role & responsibilities

• 01 Handling the Change Control Programme and functional Change Control Coordinator.


• 02 Handling of Deviation and Market Compliant.


• 03 Preparation and review of Product Quality Review.


• 04 Preparation, maintenance, review of all other QMS documentation.


• 05 Preparation and issuance of SOP's.


• 06 To maintain logbook and document control.


• 07 Issuance of format.


• 08 Reviewing of BMR / BPR.


• 09 Ensure the implementation and compliance with cGMP aspects.


• 10 Ensure compliance with Data Integrity.


• 11 Administrative Reporting to Head QA.


• 12 Functional Reporting to Deputy Manager.


• 13 Investigation in case of Incident, Market complaint, Product Recall, Out of Specification or any other factor that may affect product quality.


• 14 Implementation of Corrective Action and Preventive Action.


• 15 To participate in the SQE meeting, ensure the implementation of quality culture on the shop floor, and update the core committee on the progress of the SQE.


• 16 To review new legislation and guidelines (For WHO, EU, ICH, Others) & evaluate the need for any system updation and or resources requirement.


• 17 Preparation, Compilation and Review of CPV.