Quality Assurance Manager

Responsibilities:

• Ensure CPO compliance with the requirements of Quality Manuals and Policies and all relevant GDP processes and legislative requirements.
• Ensure that a local Quality System and Standard Operating Procedures are in place for all GDP related activities and that compliance with all GDP regulations is maintained through training and internal audits.
• Perform local quality audits and Partner in the preparation, execution and follow-up of the internal and external audits. Together with the auditees, resolve root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings. Participate in QA investigation activities, as appropriate.
• Ensure adequate training at the organization for all GDP related activities by defining, planning, and supporting training activities.
• Conduct third party activities Assessment/Qualification and Audit and ensure that third party is following organization Standards.
• Ensure organization readiness for all GDP regulatory inspections. Collaborate in all organization relevant external inspections, complaints, recalls, counterfeits, and product tampering according to the AZ Corporate Quality Manual and local written procedures.
• Ensure that all relevant drug imported products are released in accordance with the registered specifications and with local/international regulations.
• Ensure that the computerized systems are adequately identified during the High-Level Risk Assessment for GDP relevance to enable their validation where required.