Senior Quality Assurance Specialist

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Maadi, CairoPosted 9 months ago

129Applicants for1 open position

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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.