Quality Assurance Compliance Supervisor

• Managing the deviations received from different departments, investigation & root cause analysis & review of reports to be approved by QA manager.
• Management of CAPA system, ensure that all approved CAPAS are tracked and communicated to all concerned parties & manage the follow-up of CAPA plans implementation and effectiveness.
• Managing change control system, evaluation of changes & checking appropriate implementation.
• Issuance of product quality review plan and reports annually for all products.
• Handling and investigation of customer complaints till closure
• Creation and update of a plan for quality risk management in production areas, warehouses & Quality control, ensure that all potential and existing quality risks are tracked, Review quality risk management reports to be evaluated and approved by Quality Assurance Manager.
• Reviewing the layouts of production departments, warehouses & QC labs (classes, differential pressure, material flow, personnel flow and airflow).
• Review and update the major documents like Site Master File, Company Manual and Quality Policy.
• Ensure compliance with GMP pharmaceutical guidelines and ISO Standards, Quality Management System and Data Integrity
• Supervision of vendor management / supplier evaluation system including raw/ packaging materials suppliers, toll manufacturers, Bio-equivalence centers and other service providers.
• Handling external audits from different local and external regulatory bodies and licensors.
• Managing quality agreement with suppliers to ensure all contractual quality requirements are fulfilled.
• Implement the system for qualification of outsourced activities s and suppliers according to pre-set criteria and follow up annual performance to issue updated approved list.

Responsible for Internal audit program, plan issuance and execution, follow up of CAPA implementation.

• Handling cases of Recall (if any) according to approved system and procedures