To provide QA leadership and oversight for GMP audit activities, including the establishment and maintenance of a risk-based audit strategy; training and continuous development of GMP auditors, within a matrix organization; and reporting on the GMP risks, trends and effectiveness of the quality systems at Grifols Egypt.
To receive 3rd party audits, as well as Health Competent Authorities inspection.
To evaluate critical suppliers according to the established procedures based on Audits performance result and KPIs established for measuring level of cGMP compliance of product received as well as services provided.
Key responsibility
Develop, manage and oversee a global risk-based audit program to ensure effective QA oversight of GEPD GMP activities, internally and externally.
Develop, manage and oversee a system of a global qualification process of suppliers, considering Key Process Indicators (KPI), and audit performance results, that will ensure the correct evolvement of suppliers.
Initiate a formal Auditor development program, with a focus on GMP, considering selection, training, coaching, continues development, feedback on performance and qualification.
Oversee and provide feedback to Audit and Supplier Qualification specialists to discuss findings, emerging risks and identify actions to address identified risks, ensuring formal feedback is provided to senior management on a regular basis.
Provide quality direction in relation to regulatory updates as it impacts on the GEPD GMP audit program, ensuring continual compliance with policies and procedures.
Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements.
Participate in and support Regulatory inspections and aspect of notified body audits.
Establish an internal audit program to ensure that all area in the company are in compliance with Egyptian Regulation, cGMP requirements and in accordance with FDA and European standards, in order to ensure the quality and safety of final product according to the licenses approved by Health Authorities.
Academic experience required
Bachelor s Degree in Health-related Sciences.
Post-Graduate Certification in Quality Management.
Proven experience in GMP auditing within a Pharmaceutical Company preferred.
Knowledge of cGMP requirements preferred.
Auditor certification preferred.
Professional experience required Typically requires a minimum 8 years of general experience and 3 years of related quality experience Computing skills Proficiency with computers. Personal skills
Organized and able to manage time effectively.
Ability to work within a highly regulated, labor-intensive environment.
Analytical and enquiring mind with the ability to interpret data and facts.
Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups.
Effective organizational and planning skills with ability to meeting deadlines required.
