- Ensure compliance with regulatory requirements (FDA, EMA, ICH, WHO, etc.) and Good Manufacturing Practices (GMP).
- Manage internal and external audits, including CAPA (Corrective Action Preventive Action) plans.
- Stay updated on regulatory changes and assess their impact on company processes.
- Prepare and maintain regulatory documentation.
- Maintain, review, and update the Quality Management System (QMS).
- Lead the implementation of quality policies, procedures, and systems to meet corporate and regulatory standards.
- Analyze root causes of quality defects and implement corrective and preventive actions.
- Recommend process improvements based on risk management principles.
- Oversee batch record review and product release activities.
- Collaborate with production, R&D, supply chain, and regulatory affairs teams to ensure seamless QA integration into all processes.
- Participate in cross-functional meetings and provide QA insights to project teams.
- Develop and deliver training programs for QA staff and cross-functional teams on quality principles, GMP, and regulatory requirements.
- Ensure ongoing training and competency development of the QA team.
- Lead and supervise the Quality Assurance team, providing mentorship and training.
- Coordinate activities of the QA department and ensure that tasks are executed efficiently.
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field (Master’s preferred). Minimum 5-7 years of experience in Quality Assurance in the pharmaceutical industry, with at least 3 years in a leadership role. Thorough knowledge of GMP, ISO, regulatory guidelines, and quality management systems. Experience with regulatory inspections (FDA, EMA) and handling CAPAs. Strong analytical, problem-solving, and decision-making skills. Excellent communication and interpersonal skills. Ability to manage multiple tasks and projects in a fast-paced environment.