Site management for a new GMP facility in MaltaEstablishing all the procedures / suppliers / SOP’s for the new siteSupervising production processesEstablishing and recruiting the whole facility teamProduction planning and organizationConfirmation of the purchase of materials, raw materials, overview, and inventoryNegotiations and agreements with suppliersEnsuring health and safety regulationsOrganization of repairs and regular maintenance of all production equipment and preparation of annual plans for equipment maintenanceControl and supervision of environmental conditionsParticipation in GMP activitiesAssistance in the preparation and review of new technological processes and SOPsApproval of instructions in correlation with production processes, validation reports, and ensuring their executionParticipation in the evaluation of the quality system of external contractorsTo ensure that the production records are evaluated and signed by an authorized personEnsuring qualification and maintenance of department, premises, and equipmentTo ensure that the appropriate validations / assessments are performedTo ensure that the required initial and continuous training of department personnel is carried out and adapted according to needThe authorization of written procedures and other relevant documentsThe monitoring and control of the manufacturing environmentThe approval and monitoring of suppliers of materials with the cooperation of the Quality departmentThe monitoring of compliance with the requirements of Good Manufacturing Practice

Overseeing site and managing site with also the responsibility of the quality unit.Misom labs is a contract pharmaceutical QC laboratory including a Microbiology Laboratory.

-Consultancy on Quality Systems, QC approach and guidance on obtaining GMP license.

QC Manager will implement and enforce quality assurance and quality control policies and systems throughout the company to certify that products are manufactured consistently and in accordance with a stringent standard of quality. Quality Administrator will manage the quality systems databases for SOPs, training, change controls, etc. Responsible for scheduling work and all kind of analysis troubleshooting.

As a summer worker, I used to sample raw materials and perform also and FT NIR test.July 2012 was a new venture for me at arrow pharm where after completing my studies I started my work as a junior analyst were I performed various different analytical techniques such as IR, UVs, HPLC, Dissolutions, physical testing.