A Quality Assurance Manager in a pharmaceutical company ensures that all products meet strict regulatory standards and internal quality policies. They oversee the implementation of quality control procedures, conduct audits, and manage compliance with Good Manufacturing Practices (GMP). Their role is critical in maintaining product safety, efficacy, and consistency throughout the production process.
Develop and implement quality management systems (QMS).
Develop and implement Quality Management Systems (QMS) to ensure consistent product quality and regulatory compliance across all operational processes. Identify process improvements and facilitate training programs to embed a culture of quality throughout the organization. Monitor performance metrics and conduct regular audits to drive continuous improvement and maintain certification standards such as ISO 9001.
Ensure compliance with GMP, GLP, and regulatory standards.
Maintain strict adherence to GMP, GLP, and regulatory standards by implementing comprehensive quality control measures and conducting regular audits. Develop and update standard operating procedures to align with evolving regulations, ensuring consistency and accuracy across all processes. Collaborate with cross-functional teams to identify compliance gaps and provide targeted training to uphold industry best practices.
Conduct internal and external audits.
Perform comprehensive internal and external audits to evaluate compliance with industry standards, regulations, and company policies, identifying areas for improvement. Utilize auditing software and data analysis tools to ensure accuracy and thoroughness in financial, operational, and procedural assessments. Collaborate with department heads to implement corrective actions and enhance internal controls, driving continuous improvement and risk mitigation.
Oversee deviation, CAPA, and change control processes.
Manage the deviation, CAPA, and change control processes to ensure compliance with regulatory standards and internal quality systems. Analyze root causes of deviations, implement corrective and preventive actions, and maintain thorough documentation for audit readiness. Collaborate with cross-functional teams to streamline process improvements and minimize operational risks.
Review and approve batch records and quality documents.
Review and approve batch records and quality documents to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards. Analyze documentation accuracy, completeness, and consistency to maintain product quality and traceability. Collaborate with quality assurance teams to promptly address discrepancies and implement corrective actions effectively.
Manage validation and qualification activities.
Manage validation and qualification activities ensuring compliance with regulatory standards such as FDA, ISO, and GMP. Coordinate cross-functional teams to develop and execute validation protocols, analyze data, and document results to guarantee process reliability and product quality. Implement continuous improvement strategies to optimize validation procedures and maintain up-to-date documentation for audit readiness.
Train and supervise quality assurance personnel.
Train and supervise quality assurance personnel to ensure adherence to industry standards and company protocols, improving product reliability and customer satisfaction. Develop comprehensive training programs and conduct regular assessments to enhance team skills and maintain high performance. Monitor quality metrics and provide actionable feedback to foster continuous improvement and compliance.
Monitor and report on quality metrics and KPIs.
Monitor and report on quality metrics and KPIs to ensure compliance with organizational standards and continuous improvement. Utilize data analytics tools to track performance trends and identify areas for corrective actions. Provide actionable insights and regular reports to stakeholders to drive strategic decision-making and enhance overall product or service quality.
Handle product complaints and recall processes.
Manage the product complaints and recall processes by systematically documenting customer feedback, investigating reported issues, and coordinating with quality control teams to ensure prompt resolution. Implement corrective actions and maintain compliance with industry regulations and company policies to safeguard brand reputation and customer safety. Collaborate with cross-functional departments to enhance product quality and prevent future incidents.
Collaborate with regulatory agencies during inspections.
Work closely with regulatory agencies to ensure compliance during inspections by providing accurate documentation and transparent communication. Facilitate the inspection process by promptly addressing queries and implementing recommended corrective actions. Maintain up-to-date knowledge of regulatory requirements to support ongoing adherence and improve operational standards.