Quality Assurance Manager

Signium

Egypt

Ref: RP539-05

Job description / Role

Employment: Full Time

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.

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.

About the Company

Signium is a global executive search and leadership consulting firm, helping clients around the world make the right decisions at moments of strategic importance.

With more than 60 years of experience, we are experts in helping clients recruit, develop and retain the best leadership teams. This means we don't just find talent - we advise senior business leaders on developing their skills, their people and their organisations.

Our clients operate all around the world, and so do we. With offices in nearly 30 countries, we combine global reach with deep local knowledge to exceed our clients' needs - whenever, wherever, whatever. During periods of significant change, we give our clients the edge when shaping their futures.

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