Quality Assurance Section Head

Quality Activities :

• Ensures that all manufacturing process is following strictly the GMP regulations, securing, in parallel, that it will be in line with the approved SOP.
  Authorizes the final release of the products.
• Prevents any incident, before occurrence, from happening that may alter the quality of the product which in return can cause product turning back or recall or even clients’ complains.
• Ensures that required documents are available when needed.
  Sets procedures that ensure the correct handling of materials and documents.
• Performs self-audits on a regular basis.
• Performs external-audits according to Annual Plan.
• Conducts training programs on a scheduled basis.
• Solves technical problems related to product quality.
• Ensures the appropriate filing and archiving of documents.
• Works with the manufacturing management improve procedures related to quality.
• Reviews and corrects or completes documents relative to quality technical documents.
• Secures the calibration of all reading devises, as well as, the calibration and validation of all equipment by inspecting them on a routine basis.
• Makes sure that no change in the production process or the acquirement of raw materials can take place in any field without taking the appropriate measures for validation and approval.
• Reviews and approves the batch records prepared by production & Q.A. department.
• Manages & supervises departmental employees, assigns work and special projects, monitors workload and productivity, evaluates performance and promotes staff training and development.
• Identifies the required technical training and cooperates closely with HR Manager on issues of training, development, vacation schedules and makes proposals for hiring, firing, promotions, bonus and salary increases.
• Coordinates with the departments of Production, Warehouse, Engineering and HR to achieve departmental and company objectives.
• Secures the compliance with the quality, environment, safety requirements according to national and international standard (ISO 9001, 14001).
• Identifies, records and updates the various aspects within the department and their impact on the environment.
• Participates in setting implementing and amending the environmental programs.
• Determines and identifies the emergency situations in the department.
• Ensures that the disposal of waste in the department is effected in line with the waste management policy.
• Carries out periodical environmental awareness sessions to the employees in the department.
• Approves all Product Quality related documents

Compliance Activities

• Assures the compliance of Methods of Analysis to the Registered Files.
• Assures the compliance of Products Specifications to the Registered Files.
• Assures the compliance of know how of Products with the Registered Files.

Validation Responsibilities

• Manages the preparation and performance of Process Validation Protocols, Cleaning Validation, and Machines / Utilities Qualifications in coordination with QC, Production, and Engineering
• Manages the preparation and performance of Computer Validation Protocols in coordination with IT and any related Department.