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Job Description
- Develop and approve the company’s quality control policies and procedures based on local and international standards and measures for pharmaceutical industry, taking into consideration internal operating conditions.
- Follow up on developments in quality control standards for pharmaceuticals and the pharmaceutical industry locally and globally, and make any amendments to control systems and their internal policies.
- Adopt methods of analysis for new products received from Methodology section, and following up the training of the team to carry out them and provide their requirements.
- Responsible for managing and coordinating work between all laboratories and departments in the department and managing and directing employees.
- Approve analysis and examination reports for raw materials received to be released from reception store and transferred to raw material store.
- Adopt and follow-up of product samples reports during manufacturing to follow up the manufacturing quality.
- Approval of analysis and inspection reports for finished products to be released and transferred from cartons to finished materials warehouse.
- Approving environmental monitoring reports for manufacturing places and following up on microbiological analysis, especially for sterile places.
- Adopting procedures and instructions for entering and exiting different workplaces, especially sterile places and types of clothing for each manufacturing area, in accordance with quality instructions and good manufacturing conditions for medical preparations.
- Continuous communication and cooperation with the concerned departments to ensure the achievement of management objectives such as quality assurance management, research, product development, production, finance, Supply and chain, Finance... etc.
- Participate in the evaluation of suppliers and make necessary reports on technical problems from each supplier.
- Participation of senior management in determining the causes of deviation in quality, if any, at any stage, and in developing solutions and following up on their implementation.
- Develop department internal work plan and determine the periodic needs of equipment, materials and tools used in analysis, and consider this in department annual budget.
- Follow-up to the directives and instructions of the Ministry of Health regarding quality and drug manufacturing, and fulfilling its requirements in terms of preparing samples and submitting reports or statistics..etc.
- Follow up on the speed of meeting needs of other departments, such as the registration department, quality assurance, or other quality reports, or others, to complete their work.
- Applying quality and ISO instructions internally in management laboratories, operating methods and internal analysis to qualify all laboratories to obtain quality certificates for control laboratories.
- Management and organization of archives and organized databases for administration to maintain data and files of analysis, quality and release credits to other important data and to ensure the confidentiality of the data and the access to it only by the persons concerned.
- Follow up the performance of department employees, provide assistance and advice, provide necessary internal or external training in cooperation with HR Department, and approve performance reports and promotion plans.
Job Requirements
- Graduated from the Faculty of Pharmacy.
- At least 5 years of experience in same position.
- Full knowledge of all quality standards and instructions for the local and international pharmaceutical industry.
- Full knowledge of the various devices and tools used in the control laboratories.
- Administrative and technical ability to train and evaluate the experiences of his employees and to know the strengths and weaknesses.
- Administrative and technical knowledge of setting policies, procedures and annual budgets, setting goals and following them up.
- High ability to manage, supervise and direct and provide a leadership personality.
- Ability to communicate effectively, follow-up, and use all technological methods and means to do so
- Proficiency in the use of computers, especially the Office suite.
- Previous experience in ERP system for supply and follow-up.
- Proficiency in English language.
- Excellent communication skills.
