Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment?
If so, this Operational QA Manager role could be an ideal opportunity to explore.
As an Operational QA Manager, you will be responsible for providing effective and efficient support to the Local Operating Country (LOC) Quality Manager to maintain effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS and local regulations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following :
Execute and deliver Local Operating Country (LOC) Quality Objectives and LOC Quality Improvement Plan.
Perform trending of Quality KPIs to support continuous improvement at the LOC.
Maintain a robust, sustainable and effective QMS (Quality Management System) at the LOC to ensure LOC Quality operations and processes are in full compliance with GSK standards and policies, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and local regulatory requirements.
Responsible for quality performance of the assigned 3rd party contractors / service providers / suppliers and ensuring potential quality and compliance issues are identified, communicated and promptly resolved.
Ensure quality systems are in place and in use according to GSK QMS standard.
Coordinate LOC Quality Council meetings.
Participate in LOC Quality Council(s) in identifying Quality related issues and continuous improvement Opportunities.
Perform activities to support risk management process to ensure timely mitigation of quality risks.
Perform quality impact assessment to ensure all planned changes at the LOC are appropriately managed.
are appropriately managed through change control.
Perform self-inspections at the LOC and 3rd party service providers’ operations with potential product quality and regulatory compliance impact.
Support investigations and root cause analysis in response to deviations, quality issues, audit findings and customer complaints.
Ensure product supplied to market have the right quality, safety, efficacy and comply with local regulations.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
5 years of experience in life sciences industry in Quality Assurance role
Experience with cGMP (Clinical Good Manufacturing Practices) in pharma testing / secondary repacking
Operational experience with Good Documentation Practices (GDP) in warehousing and distribution
Preferred Qualifications :
If you have the following characteristics, it would be a plus :
Ability to engage and works well works well in cross-functional teams
Ability to multi-task and work under pressure