Support the Quality Assurance department, perform tasks for SOPs management, quality metrics, quality control process, archiving and documents update in order to ensure that FCS is compliant with global and local regulatory requirements, good manufacture, documentation and distribution practices. All these activities must be carried out according to the specifications, systems and information technologies/administrative tools required by the company and/or client.
 
 
Essential Duties and Responsibilities:
 

1. Provide support to quality assurance and quality control activities in order to accomplish with quality company’s policies, based on the good manufacturing, distribution, clinical and documentation practices, and client requirements
2. Ensure the correct execution of the operational processes as established in the current SOPs
3. Perform local SOPs updates based on the Global SOPs, local regulations, and local operational requirements.
4. Manage GxP trainings distribution via LMS system and/or classroom
5. Manage issuance, revision, obsolescence and archival of Quality documentation based on Good Documentation Practices
6. Participate follow up on validation, qualification, maintenance, and calibration of equipment and GxP areas
7. Perform and follow up on self-inspection audits
8. Support on supplier assessments, audits, qualification and elaboration of Quality Technical Agreement       
9. Provide support in Quality Control activities such as physical inspection and batch release of receipts in the quality system (GPM and CTWin), shippers and materials inspection and release, check and release of relabeled materials (GPM system and manual form) and check of shipments as client requirements.
10. Support on client/regulatory audits
11. Support on KPIs elaboration
12. Quality follow up in Deviations, Complaints and CAPAs development
13. Ensure the correct execution of operational processes
14. Development of all activities with safety and efficiency manner

1. Pharmacy graduation
2. Knowledge of GMP Standards and local regulations.
3. Knowledge of Outlook, Microsoft Office Package, Internet.
4. Experience in the area of quality assurance and logistics activities.
5. English intermediate level