Provides effective and efficient quality assurance systems support to the Quality Manager, including supporting the implementation and maintenance of the QMS (Quality Management System)
•Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
•Support the Quality Manager to ensure a robust, sustainable and effective QMS through monitoring and reviewing the compliance status
•Ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies, GMP, GDP and regulatory requirements by supporting the Quality Manager as directed to:
- Ensure that all SOPs are in place, updated & training has been conducted across the business.
- Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance.
- Review, conduct impact assessments and implement any updates to QMS policies
- Identify, Implement and Manage QA Objectives & KPIs
- Establish and manage Annual Quality Plans
- Support the LOC Quality Manager in organizing regular Quality Council meetings.
- Support the local change control process with the aim of ensuring all planned major changes (e.g. new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed.
- Support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.
- Implement global or local process to effectively manage corrective and preventative action plans.