Quality Assurance Executive

Role & responsibilities

To execute CAPA management for respective accounts,

• To initiate CAPA in ETQ system as per timeline.
• To do root cause analysis as per procedure
• To Implement corrective and preventive actions
• To do Effectiveness review
• To prepare CAPA Action plan and share to regional Quality officer for review  
• To maintain CAPA Log to track CAPA for timely closure

To initiate Change control in ETQ system and Maintain Change control log as per SOP

To identify and initiate deviation, submit deviation to regional Quality officer for review and close the deviation as per procedure

To Prepare and maintain housekeeping checklist, Pest control service records, warehouse trap and flycatcher checklist and update the Records

Responsibilities related temperature / humidity monitoring and management                        ( if applicable),

• To prepare and maintain temperature and humidity data log on regular basis .
• To take immediate necessary action in case of temperature escalation beyond specified limits .
• To Notify temperature excursion immediately to customer or Regional DHL QA .
• To find out root causes and implement necessary actions .

Training management and document management 

• To complete self-training assessment as per schedule
• To prepare site master file periodically 
• To prepare calibration/ validation schedule 
• To prepare respective site training matrix, training schedule and maintain training log and to keep update on real time basis.
• To maintain Quality data as per defined retention period.
• To maintain training questionnaire viva sheet for each employee at site for applicable personnel as per training matrix.
• To archive and maintain all operation/Account specific  QMS related Document. (E.g.: Inbound, outbound, inventory count, calibration record, validation record, daily temperature record, housekeeping records, deviation copies and thermal mapping reports in etc.)

To track the due date of Calibration & maintenance for instruments 

To update Yearly calibration schedule & maintenance schedule after activity is completed

Responsibilities related Audit management ,

• To proactively provide all required documents for Customer/ external (ISO) /internal audits 
• To raise Non-Conformance ( NC) as per set timelines 

Timely monitor Equipment qualifications and area qualifications (Temperature Mapping) due dates and update site manager to plan the activity. After completing the mapping duly fill the post mapping checklist & repositioning the sensor as per latest mapping report

To verify all AMC copies, pest control service, AC Maintenance and DG set in etc.  and update site manager /account in charge for renewal of AMC.

To Notify the regional quality officer in advance before adding or changing any supplier service provider.

Complaint Management ,

• Timely log customer complaints as per procedure 
• To immediately inform customer and Regional Quality officer detaisl related to complaint 
• To do complete complaint investment as per procedure
• To raise CAPA in ETQ system 
• To close the complaint with necessary actions

To do Identification of nonconforming product, segregation (Quarantine area), and communication to customer & regional quality officer.

To support for product recall, product identification & traceability and storage & Reconciliation.

To prepare the role profile for self in ETQ format & to do signoff periodically .

• To identify and report the damaged / expired goods and communicate with customer/DHL Quality office immediately
• Take necessary actions after destruction approval received from customer

To Track due date of Revision of operation SOP.

Operations Responsibilities

1 Facilitate the planning and coordination of Operation activities for a respective account

2 Support implementation of policies and procedures for maintenance and continual support of the Quality System in support of the business.

3 Preparation of document /record in SAP and ETQ system.

4 Monitoring of Inbound and outbound activities

5 Monitoring Supervisor/ DEO/ Warehouse assistant/ Material Handler with Job allocation

6 To be conversant with good documentation procedure and ensure that the requirements are followed and not compromised, challenge all improper practices and resolve non-compliance or report or report to supervisor

7 Facilitate timely maintenance and calibration of instruments & update records

8 To process orders. Generate & verify pick slip in the system. To pick the materials as per pick slip, packing the picked materials and handover to transporter

9 To confirm loading/unloading of shipments and reporting discrepancies to supervisor.

10 Take corrective actions against customer complaints and records maintain.

11 To perform Inventory cycle counting as per procedure and reporting to supervisor if any variations are noticed