Dima Sara Email & Phone Number

Saint-Laurent, Quebec, Canada

Review all documentation related to manufacturing and packaging release process as per Regulatory and Internal requirementsCreation and implementation of CAPA and deviations Examine all current processes to ensure continuous improvement of systems in place (Updated investigation process, destruction process and change control process) Lead bi-weekly meetings with all suppliers to address any issues and areas of improvementEnsure communication with purchasing department and warehouse quality team to manage weekly prioritiesInitiate change controls Assess risk and impact of every change introduced by the suppliers or internallyManage Validation Project (follow up with all suppliers to compile complete process, packaging and analytical method validation evidence as requested by Health Canada)

• Manage Master and production Files• Implement changes required by clients and/or Regulatory agencies (Health Canada, FDA…)• Participate in internal and external quality audits• Follow up with clients and creation of non-compliance reports, deviation and complaints• Verify conformity of production files • Communicate daily with clients and internal departments (planning, customer service, production…) • Primary replacement of quality supervisor in management of all activities • Ensure a constant follow-up and support of production • Release of all components received and final products• Investigate problems and create follow-up reports• Assistant Qualified Person in Charge (AQPIC)• Create and update Standard Operating Procedures

Project Management Professional

Bachelor Of Science (Bsc), Biochemistry