Job description / Role
Quality Assurance Manager - For one of our clients in the Pharmaceutical Industry
Our client is a Multinational Pharmaceutical Company that is searching for a Quality Assurance Manager who will be responsible for the following.
• Ensure that GMP standards are applied based on MOH requirements and standards.
• Design, implement and improve QA systems and auditing procedures.
• Review and approve the Company SOP’s, validation, Qualification, Protocols, Annual review, batch record, and manufacturing record.
• Coordinate final review of all batch-related documentation and release of finished product.
• Establish in process product inspection standards with other members of management by studying manufacturing methods; devising testing methods and procedures.
• Share in the preparation of quality-related audits conducted by corporate and regulatory agencies.
• Responsible for ISO Quality Management System Certification maintenance; development of site internal audit annual plan; and implementation of this plan.
• Collect site supportive information for preparation of the variation/changes documentation.
• Design the evaluation program for suppliers and contractors and ensure the proper implementation.
• Design the program for facility sanitation and hygiene and the monitoring of performance.
• Establishes product quality documentation system by writing and updating quality assurance procedures.
• Drive local documentation control system on regulatory changes activities.
• Responsible for QA resource planning including preparation of budgets and monitoring budget adherence.
• Assure that all deviations are properly investigated prior to the release of the batches.
• Managing all quality issues regarding investigations, complaints and recalls.
• Oversight for Art Work design.
• Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured in plant.
• Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions and re-validations.
• Fulfill other related tasks as asked by management and as arising from the business.
• Responsible for the fulfillment of all requirements related to the GCC certification.
Our client is a Multinational Pharmaceutical Company that is searching for a Quality Assurance Manager who will be responsible for the following.
• Ensure that GMP standards are applied based on MOH requirements and standards.
• Design, implement and improve QA systems and auditing procedures.
• Review and approve the Company SOP’s, validation, Qualification, Protocols, Annual review, batch record, and manufacturing record.
• Coordinate final review of all batch-related documentation and release of finished product.
• Establish in process product inspection standards with other members of management by studying manufacturing methods; devising testing methods and procedures.
• Share in the preparation of quality-related audits conducted by corporate and regulatory agencies.
• Responsible for ISO Quality Management System Certification maintenance; development of site internal audit annual plan; and implementation of this plan.
• Collect site supportive information for preparation of the variation/changes documentation.
• Design the evaluation program for suppliers and contractors and ensure the proper implementation.
• Design the program for facility sanitation and hygiene and the monitoring of performance.
• Establishes product quality documentation system by writing and updating quality assurance procedures.
• Drive local documentation control system on regulatory changes activities.
• Responsible for QA resource planning including preparation of budgets and monitoring budget adherence.
• Assure that all deviations are properly investigated prior to the release of the batches.
• Managing all quality issues regarding investigations, complaints and recalls.
• Oversight for Art Work design.
• Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured in plant.
• Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions and re-validations.
• Fulfill other related tasks as asked by management and as arising from the business.
• Responsible for the fulfillment of all requirements related to the GCC certification.
Requirements
• The ideal candidate will be a Quality Assurance professional who has a very strong experience in sterile areas. He should also have the GCC auditing experience and his previous employer should have passed it.
• 15 to 20 years of professional experience in multinational pharmaceutical companies in Egypt with a strong experience in sterile area and GCC audit.
• Age range is preferably in late 40s.
Key Demographic Requirements - applicants must be:
- Based in Egypt
- Egypt National
- Fluent Arabic Speaker
- Minimum Age: 45
- Maximum Age: 60
• 15 to 20 years of professional experience in multinational pharmaceutical companies in Egypt with a strong experience in sterile area and GCC audit.
• Age range is preferably in late 40s.