Job Description
Provides effective and efficient quality assurance systems support to the Quality Lead-Gulf, including supporting the implementation and maintenance of the QMS and as directed by the Quality Lead-Gulf, performs the day to day work to ensure that the quality systems required by the Gulf element of the Supply Chain and Marketing Company Gulf are performed in a lean and efficient way and meet the compliance standards of the QMS and the local Regulator(s).
Key Responsibilities
Describe the key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role.
Quality Strategy
- Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
- Gain an understanding of the Supply Chain and Commercial Business and Quality Plans at a high as they potentially link to day to day and quality improvement activities.
Quality Systems
- Supporting the Quality Lead-Gulf to ensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the element of the Supply Chain and Gulf Marketing Company.
- Change Control - perform day to day work to support the local change control process with the aim of ensuring all planned major changes (including as appropriate new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed. Processes in place to routinely review progress of changes and close out when completed.
- Risk Management - perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.
- Corrective and Preventative Actions (CAPA) - Implement global or local process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop CAPA’s. Local process in place to track and review CAPA plans on routine basis. Demonstrate that Gulf effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out.
- Auditing - perform day to day work to support the local process that is in place for MM and IBM auditing. Work with the Quality Lead-Gulf to ensure:
� The MM and IBM auditing process includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management.
� MM and IBM audit universe is defined and agreed with Regional Quality and annual audit schedules in place.
- Complaints - perform day to day work to support an effective complaints management process ensuring
� the assessment of potential issues are determine as quickly as possible and linked to the adverse event reporting process and local product incident process if/as appropriate.
� report and follow up on product complaints with manufacturing sites, customers and commercial teams.
