Job Description

Department Details
Role Summary
2 Assistant Manager/ Deputy Manager/
Manager o To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.

• Employees who are involved in GMP activities should undergo a mandatory cGMP training.
• Frequency of mandatory basic training is once in a year
• All employees that involving with GxP environment should undergo a mandatory basic microbiology training
• To provides information, guidance and recommendations to facilitate compliance with DI, GDP in documentation.
• To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
• Responsible for assigning the non-conformance to the team members
• Responsible to represent the team for weekly update to the management on team progress
• Responsible to review the investigation report and impact assessment for internal review prior to CFT review
• Responsible to provide technical input in the write-up
• Responsible to escalate the challenges faced to the higher management
• Responsible to lead the investigation for finalising the investigation approach
• Responsible to lead the discussion with CFT for any decision making.
• Responsible to brainstorm with CFT for any challenges faced.
• Identifying the training requirement for the team.
• Tracking of events, OOS OOT upon initiation by user
• Maintaining and updating the tracker on daily basis for current status
• Notifying team for new non-conformance
• Provide reminder for nearly due non-conformances.
• Managing and updating each task using Microsoft Team.
• Maintaining the template for any of the SOP annexures as document controller.
• Updating and revision of Organizational Chart for SIT department, whenever applicable

Setting team and individual activities and planning to meet departmental , business unit and company objectives.
Act as a point of contact for team members queries and escalations with regards to complex matters
Key Responsibilities
2 Assistant Manager/ Deputy Manager/
Manager o To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.

• Employees who are involved in GMP activities should undergo a mandatory cGMP training.
• Frequency of mandatory basic training is once in a year
• All employees that involving with GxP environment should undergo a mandatory basic microbiology training
• To provides information, guidance and recommendations to facilitate compliance with DI, GDP in documentation.
• To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
• Responsible for assigning the non-conformance to the team members
• Responsible to represent the team for weekly update to the management on team progress
• Responsible to review the investigation report and impact assessment for internal review prior to CFT review
• Responsible to provide technical input in the write-up
• Responsible to escalate the challenges faced to the higher management
• Responsible to lead the investigation for finalising the investigation approach
• Responsible to lead the discussion with CFT for any decision making.
• Responsible to brainstorm with CFT for any challenges faced.
• Identifying the training requirement for the team.
• Tracking of events, OOS OOT upon initiation by user
• Maintaining and updating the tracker on daily basis for current status
• Notifying team for new non-conformance
• Provide reminder for nearly due non-conformances.
• Managing and updating each task using Microsoft Team.
• Maintaining the template for any of the SOP annexures as document controller.
• Updating and revision of Organizational Chart for SIT department, whenever applicable

Setting team and individual activities and planning to meet departmental , business unit and company objectives.
Act as a point of contact for team members queries and escalations with regards to complex matters
Educational Qualifications
Required Education Qualification: B.Sc
Required Experience: 1 - 5 years

Skills Required