Responsibilities :

• Ensure that activities related to the production quality are conform with the company policies and Corporate Quality directives. Main contact in case of production deviation,
• Lead and manage deviations, including those related to production, maintenance, packaging, and laboratory activities, by driving and coordinating investigations in collaboration with the relevant functions,
• Define, implement, and follow up on corrective and preventive actions (CAPA) within the scope of responsibility, ensuring timely execution and effectiveness in line with defined deadlines,
• Manage complaints investigation,
• Participate to the review and approval of the validation/qualification documentation related to production area,
• Ensure the creation, review, and timely update of QA Operations documents,
• Review/approve for issuance of GMP documents related to production area (SOP’s, specifications protocols, reports..),
• Participate in and/or lead risk analyses, in collaboration with cross-functional teams,
• Participate to change control process,
• Auditor in self-inspections and external audits (lead auditor if qualified),
• Support external audit, notified Bodies and Regulatory Authorities,
• Audit trail review of GMP systems.
• Training for classified area
• Review production batch records
• Release incoming consumables
• Review packaging batch records
• Promptly report any Quality Alert or issue to the Operations Quality Manager and the Quality Unit Manager and actively contribute to the resolution of significant quality issues.
• Ensure effective communication and collaboration with Production, Maintenance, Packaging, and other relevant functions to support product quality throughout its lifecycle Management
• Indirect management of investigation teams.