Job Description

Job Summary

This position is responsible for the site\'s change control management, record management, document control and GxP Training for compliance to ISO 13485, MDSAP, EU MDR and, Alcon Standards and Policies

Job Responsibilities

Lead and drive the change control, record management, document control and GxP Training Day to day operations and activities, and timely reporting of quality metics.

Supervise, provide guidance, coaching and training to the team to improve competency of the team, and responsible for team\xe2\x80\x99s objective settings, performance review and development plan.

System Admin role for LMS, and document system, co-authoring of documemts, management of document distribution activities and periodic review, approval and backup authorization matrix.

Subject Matter Expert in GxP Training, ensure effective and efficiency of Site training need, training program and training system

Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary.

Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.

Perform, review and/or approve Site\'s investigation (NCR, SAR, OOS, Complaints, etc) and Site\'s WI/SOP/Gap Assessment/Impact Assessment.

Administrator of change control, lead/host change request review with approvers and ensure change request completeness prior approval and closure.

Support internal and external audits and is responsible for audit finding closure, as required.

Provide assistance to supervisor in preparing, presenting and managing cost centre budget and forecast accuracy

Backup to the Supervisor.

Performs any other duties as assigned by Supervisor according to business needs

Job Requirements

Diploma or Degree in any Science related courses

Min 5 years\' experience and 2 years in supervisory role preferred from medical device or pharmaceutical backgrou

Certified internal auditor \xe2\x80\x93 ISO 13485 added advantage

Alcon