Quality Assurance Manager

Hamdard Pakistan is seeking a knowledgeable and detail-oriented Quality Assurance Manager to lead its Quality Assurance function and oversee the companys Product Quality Management System (PQMS). In this critical role, the manager ensures that all manufacturing and quality processes comply with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), World Health Organization Good Manufacturing Practices (WHO-GMP), Drug Regulatory Authority of Pakistan (DRAP), and relevant international regulatory standards. The role requires spearheading batch disposition, validation, qualification activities, thorough documentation, and regular quality audits to uphold high-quality production standards. This position requires a dynamic leader with at least seven years of progressive experience in quality assurance within the pharmaceutical or related regulated industries. The Quality Assurance Manager will manage a team of eight professionals, fostering a culture of continuous improvement and operational excellence. This includes driving initiatives that enhance product quality, streamline compliance processes, and address corrective actions promptly. The role demands exceptional organizational skills, deep regulatory knowledge, and the ability to effectively coordinate cross-functional teams to meet company and regulatory expectations.
Responsibilities

Lead and manage the Quality Assurance department, including a team of eight professionals, ensuring effective execution of quality initiatives and compliance activities.
Develop, implement, and maintain the Product Quality Management System (PQMS) in alignment with cGMP, GLP, WHO-GMP, DRAP, and applicable international standards.
Oversee batch disposition procedures ensuring only quality-approved products proceed for distribution, maintaining thorough documentation of all quality decisions.
Plan, coordinate, and execute validation and qualification activities for processes, equipment, and systems to meet regulatory requirements and internal standards.
Conduct regular quality audits internally and with external suppliers or contractors to assess compliance, identify gaps, and implement corrective actions.
Drive continuous improvement initiatives targeting enhanced product quality, reduced deviations, and increased operational efficiencies within the quality system.
Maintain up-to-date knowledge of regulatory changes and industry best practices and ensure timely communication and implementation of necessary adjustments.
Collaborate closely with production, regulatory affairs, research and development, and other departments to uphold quality standards throughout product lifecycle stages.
Prepare and present detailed quality reports and metrics to senior management, highlighting issues, risks, and trends to support informed decision-making.
Manage and ensure proper training for quality assurance staff and relevant personnel to sustain high competency levels and regulatory compliance.