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
