Main Responsibilities
As part of ensuring regulatory compliance, the manager must ensure that all activities relating to the manufacture, quality control and distribution of pharmaceutical products scrupulously comply with local and international regulatory requirements.
It is also responsible for managing documentation. It is responsible for creating, revising and managing quality documentation, including standard operating procedures (SOPs) and quality manuals.
Internal and external audits are planned and carried out under his supervision, assessing compliance with quality standards. In addition, he or she may be involved in managing external audits conducted by regulatory bodies and customers.
In terms of change control, the Quality Assurance Manager monitors and assesses changes to processes, systems and products to prevent any negative impact on quality.
In the event of deviations from specifications or procedures, it assumes responsibility for investigating and implementing corrective and preventive measures.
Training staff in quality procedures and good manufacturing practice may also be part of its responsibilities.
Finally, the Quality Assurance Manager frequently works with suppliers, ensuring the quality of the raw materials and components used in the manufacture of pharmaceutical products.