Quality Assurance Officer

• We make patients our priority
• We act with integrity and accountability
• We work together as one team

• We look for better ways forward

• Assist in maintaining and/or updating the GMPD license issued by the FAMHP and the ISO/MDD/MDSAP Certification issued by the Notified Body.
• Assist in obtaining MDR Certification issued by the Notified Body.
• Ensure continuous support in the electronic ERP (system) (SAP) (Keyuser role)
• Drafting and updating of the internal quality procedures of SERB
• Ensure maintenance and follow-up of administrative tasks in the electronic documentation management system (eDMS) (eDMS admin role)
• Assist in the monitoring of Key Performance Indicators (KPI)
• Assist in the preparation of the management / quality review
• Assist in the management of non-conformities linked to electronic systems and general QMS;
• Proposal, implementation and follow-up of quality actions : corrective and preventive actions (CAPA) ;
• Monitoring and follow-up of Change Control linked to electronic systems and general QMS
• Ensure continuous support in the electronic quality management system (eQMS) (Superuser role)
• Assist in the roll-out of additional modules in the electronic quality management system (eQMS)
• Support the quality approval of artwork
• Assist in ensuring that a system of initial and continuing training is in place both manually and electronically (eLMS).
• Assist in initial and continuous training at the level of electronic systems and general QMS
• Audits:

• Monitors the regulations in force and their evolution.

• Train any new users in SAP in their domain/business area (see SAP Security Procedures document on onboarding new users in SAP)
• Share information with end users on SAP Support Procedures as and when is necessary
• Be the first point of contact for end users on any SAP related topic. Resolve if possible the issue and communicate the resolution to the end user. When necessary, the Key User may escalate to BSM and MDM (IT) (via the ticketing tool - Mantis)
• Attend the monthly Key User Group meetings with BSM and MDM (IT)
• Maintain and update Business Procedure documentation and Work Instructions - ensure all documentation is stored in the agreed SharePoint location
• Document detailed requirements for new development: Work with the BSM and MDM (IT) on producing written specifications for new requirements - defining ROI and requirements in order to progress further
• Carry out UAT for any new developments in SAP for their domain. Write test scripts where necessary to structure and guide the necessary tests to ensure all business functionality required is delivere

• Train any new users in the different modules of TWD / CW
• Be the first point of contact for end users on any TWD/CW related topic. Resolve if possible the issue and communicate the resolution to the end user. When necessary, the SuperUser may escalate to corporate eQMS team (via the ticketing tool - Hornbill)
• Support in solving tickets raised through Hornbill related to electronic QMS systems
• Support the progression of documentation through the documentation processes
• Amend any document information within the systems to meet the needs of the organization DMS
• Responsible for managing the eDMS system in day-to-day activities, including supporting progression of training items through the documentation processes (Final Approval).
• Additional duties of the eDMS admin includes managing allowed authors, unlocking documents,

• Managing the eLearning Management System (eLMS) in day-to-day activities, e.g., the addition of users, addition of new and amended, update of curricula, training requirements and scheduling of training

SERB Pharmaceuticals