Ø  Work closely with national / international Authorities Body to maintain current guidelines, certifications and approval on new products and facility.

Ø  Participates in, completes study, manages clinical data and regulatory activities parallelly.

Ø  Present company’s technical data to internal / external audit groups as required.

Ø  Ensure continuous conformity of Shariah requirements in all activities within company.

Ø  Monitor the implementation of Shariah requirements.

Ø  Report to top management on Shariah matter including Shariah non-compliances.

Ø  Lead and manage the QA team, providing guidance, training, and performance evaluations for team members.

Ø  Plan and conduct internal and external audits and inspections to assess compliance with quality standards, regulations, and company policies, ensuring timely completion of audit activities and follow-up on corrective actions.

Ø  Monitor risk assessments and identify areas for improvement to enhance the efficiency and effectiveness of quality processes.

Ø  Handle, manage and review all manufacturing documentation including, but not limited to standard operating procedures (SOPs), validation protocols, supplier audit, material in-coming, complaints, In-Process documentation, fill and finished / packaging and all department reports / records.

Ø  Analyze and approve environmental monitoring data, proposing corrective actions for any deviations.

Ø  Collaborate with cross-functional teams to implement quality improvements, including process optimization and product enhancements.

Ø  Lead investigations into critical deviations, product complaints, and non-conformance incidents, ensuring thorough root cause analysis and timely corrective and preventive actions.

Ø  Implement and maintain CAPA program to address quality issues and drive improvements.

Ø  Approve supplier evaluations, audits, and performance monitoring to ensure the quality of incoming materials and services.

Ø  Coordinate with regulatory bodies on matters pertaining to the QMS, ensuring compliance with regulatory requirements and addressing any issues that arise.

Ø  Review and approve product release decisions, ensuring that products meet the required quality standards before release.