Operational Quality Oversight

Job description

Are you energized by a Quality Assurance role that allows you to accelerate compliance in a highly technical and regulated environment?  If so, this Operational Quality Oversight role could be an exciting opportunity to explore!

As an Operational Quality Oversight, you will be responsible for providing quality oversight at Production shop floor by conducting gemba, supervision, observation, coaching, and review of process, procedure, and documentation in order to support end to end supply of quality products based on regulatory standard and GSK Policy.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

• Conduct real time investigation of incident, event, deviation, and other non-conformance to ensure that proper categorization and proper investigation is performed to addressed the issue
• Provide real time quality impact assessment of any nonconformance/issue which has potential impact to product quality
• Supervise in-process control (IPC) and other critical process in production area to ensure activity is conducted in compliance with applicable LSOP
• Support qualification process of equipment and instrument by reviewing Qualification document and involved in the execution.
• Perform batch documentation review to ensure that all products are manufactured in accordance with cGMP and QMS compliance from end to end manufacturing process
• Perform CAPA Effectiveness check
• Conduct Quality Management System Gap analysis for topic related to Quality Assurance
• Ensure an effective process is in place for the training activities of all shift personnel
• Mentoring and coaching of shop floor member in all relevant aspects of GMP
• Monitor batch record review conducted in effective and compliance manner to ensure process compliance
• Demonstrate and lead by example for the implementation of Good Documentation Practice

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor degree, preferably Pharmacist
• 1-3 years of experience in related field, fresh graduates are welcome to apply

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Knowledge of cGMPs, local and international regulatory requirements
• Strong analytical, numerical and reasoning skills
• Able to work in teams effectively
• Basic knowledge in manufacturing operations
• Good technical writing and verbal communication skills in English
• Good organization skills
• Ability to effectively summarize findings and draw conclusions, considering interfaces/ links between quality processes
• Good work ethics
• Strong interpersonal and communication skills