ASSISTANT MANAGER

Requisition ID 19108 – Posted – BIOCON SDN BHD – SITE INVESTIGATION TEAM – Malaysia

Position : 2 Assistant Manager / Deputy Manager / Manager – Focus : Site Investigation Team – Location : Malaysia

Key Responsibilities

• 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 are involved with GxP environment should undergo a mandatory basic microbiology training.
• To provide 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 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 elevate the challenges faced to the higher management.
• Responsible to lead the investigation to finalize 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 a daily basis for current status.
• Notifying team for new non‑conformance.
• Providing reminder for nearly due non‑conformances.
• Managing and updating each task using Microsoft Teams.
• Maintaining the template for any of the SOP annexures as document controller.
• Updating and revising the Organizational Chart for SIT department, whenever applicable.
• Setting team and individual activities and planning to meet departmental, business unit and company objectives.
• Acting 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

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