رئيس قسم مراقبه الجودة والضمان

Job Requirements
As part of our portfolio expansion within one of its asset G42 Healthcare; we are establishing a manufacturing capability, which will safely, effectively and efficiently manufacture of selected biological products to meet health authorities and customer expectations.
JOB OVERVIEW
To plan, direct, oversee and control the activities of the Quality Control and Assurance Department at G42 manufacturing site to ensure that key intermediates supplied from the facilities meet defined quality standards and all activities connected with their manufacture are in compliance with customer and regulatory requirements.
JOB RESPONSIBILITIES
• Co-ordinate, direct and ensure that quality-related systems, policies and procedures across the site are relevant, correct and representative of current best practice(s).
• Ensure full compliance by the site to meet G42, International and national requirements as outlined in site Quality Management System.
• Quality Assurance approval of production lots to be released
• Support manufacturing on the development and establishment of infrastructure and processes related to the transfer of new production processes / technology between R&D/manufacturing plants, or introduction of new products into the plants in compliance with all regulatory requirements such that regulatory approval can be acquired in an efficient and timely manner.
• Provide input for the timely preparation and updating of submissions of Annual Reports for authorities as required.
• Ensure the establishment of an effective and comprehensive internal audit system to evaluate the performance and compliance of all factory activities against the site Quality Management System.
• Develop and use performance measures to track laboratory and batch release performance to gauge, monitor and improve service quality to customers (internal and external).
• Ensure development of staff skills and knowledge through the provision of training, job enlargement, assistance with objective setting and broadening of responsibilities to grow with the business.
• Ensure that the operations of the department are carried out in a safe and cost effective manner with due regard to occupational health / hygiene and the environment requirements of the site.
• Develop and manage the budget for the Department to ensure achievement of operational targets.
• Provide active input into the development of Quality policies and procedures relevant to Pharmaceuticals standards and regulatory expectation
• Ensure the site is kept fully aware of, and implements as appropriate, latest regulatory compliance requirements.
• Plan, direct and oversee all external regulatory audit on site
Work Experience
DESIRED QUALIFICATIONS AND EXPERIENCE
• 12+ years of relevant work experience in a regulated operational environment with at least 5 years in a managerial capacity within pharmaceutical operations
• Bachelor/ Masters degree in a Science/ Engineering related discipline
• Very good knowledge of GMP and Biopharmaceutical quality requirement
• Sound knowledge and on-going awareness of regulatory requirements and standards
• Good knowledge of regulatory expectations; FDA/EMEA exposure
• Good knowledge of analytical techniques and general pharmaceutical technology in both primary and secondary manufacture/testing
• Excellent communication skills in both written and spoken English; ability to express complex concepts clearly and simply
Desired:
• Excellent leadership skills in team based management
• Familiar with regulatory compliance issues
• Good interpersonal and communications skills
• Good facilitation and presentation skills
• Good organizational skills
• Communication skills in Arabic is desirable