- Investigation the deviations received from different departments, investigation & root cause analysis & review of reports to be reviewed by compliance supervisor.
- Implementation of CAPA system, ensure that all approved CAPAS are tracked and communicated to all concerned parties & follow-up of CAPA plans implementation and effectiveness.
- Implement change control system, evaluation of changes & checking appropriate timeline implementation.
- Implement of product quality review plan and initiate reports annually for all products.
- Investigation of customer complaints.
- Implementation of the 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 by compliance supervisor.
- Ensure compliance with GMP pharmaceutical guidelines and ISO Standards, Quality Management System and Data Integrity
- tracking of vendor management / supplier evaluation system including raw/ packaging materials suppliers, toll manufacturers, Bio-equivalence centres and other service providers.
- Participate in Handling external audits from different local and external regulatory bodies and licensors.
tracking 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.
- Share in Internal audit program, plan issuance and execution, follow up of CAPA implementation.
Proven work experience as a Compliance Specialist or similar roleStrong analytical and critical thinking skillsExcellent verbal and written communication skillsDocumenting and reporting skillsComputer knowledgeGood English languageProficiency in MS Office (MS Excel & word)