• Job Purpose:

• Managing Quality Assurance Department to assure compliance of site manufacturing processes to regulatory and recognized international standards of pharmaceutical industry.
• To provide the market with safe, potent and effective pharmaceutical products.
• To assure compliance of all ADWIA processes to current Good Practices for manufacturing, laboratory, storage, and engineering processes (cGMP, GLP, GSP and GEP) as per recognized regulatory and international standards in addition to comply EDA regulations and its update.

Main Functions

Essential Functions

• Manage quality management and ensure continuous improvement in Quality design, quality control and quality improvement.

• Mange all external audit from regulatory Audit MOH -EDA . and other regulatory parties in addition to ISO compliance audits. And external audit from importing countries and KB as well.

• Managing Calibration, Qualification [IQ/OQ/PQ] and Validation processes; QA in cooperation with production, quality control and Engineering assures that the formal programs to checks all critical instruments for proper calibration are in place and approval of calibration process is implemented in due time. QA is responsible for qualification for equipment, utilities and systems and validation of manufacturing and QC processes.

• Managing In-Process control processes and apply and control all in-process control sampling, measurements and testing procedure, and check process capability.

• Check compliance of applied procedure to approved documented standards.

• Assure Standard Operating Procedure Approval and Management; Coordinate, approve and audit the standard operating procedures system in the company through issuance of standard operating procedures by the quality assurance department.

• Master documentation issuance, review, and approval in addition to overseeing the process of issuance, reviewing and approval of all technical and regulatory aspects of the master production, packaging. Control, etc. departments.

• Issuance of batch processing and packaging records for production purposes as QA verifies that the system of issuance BR for each BOM is implemented accurately and precisely.

• Holds Quality Annual Review by Conveying all regulatory/company quality policy statement in written format through documented quality systems, procedures covering the overall activities, which impact on quality within the organization.

• Establishing Plant Master Files and Oversees preparation, revision, approval and regular update of Site Master File, Validation master plan and quality master documents.

• Conduct cGMP/Quality training as Plan, execute, coordinate and assess the personnel training program and assure that proper records of the whole processes are kept through formal training program that tracks personnel training requirements.

• Plan and implement Self-inspection/internal quality audits and review the performance and carry in-house audit program to enhance compliance level to cGMP and proactively promote improvement through conducting internal audit program and quality self-inspections in all departments to ensure the implementation of quality policy and cGMP requirements.

• Revise suppliers Qualification and Supplier approval with other concerned departments (e.g. QC, purchasing. ..etc.) conducts the program in compliance with cGMP, to qualify suppliers of product components on a routine basis to assure their compliance with cGMP and delivery of quality standards.

• Perform periodic audits Toll manufacturing audits [production by third party to assess technical and cGMP compliance.

• Managing of change control and reviews all documentation and approve it prior to change implementation through Formal control procedures which requires sign off agreement prior to change implementation to any equipment, utility or procedure affecting manufacturing or QC facility.

• Prepare deviations and CAPA (Corrective / Preventive Action) management System for all excursions from specifications or process norm require investigation and formal report prior to conclusions reached and decision taken for products or processes.

• Coordinating Complaint Management System of all technical product complaints and to liaise with medical department through formal program to assure that complains are appropriately investigated by the various functions and properly documented and reported to assure customer satisfaction.

• Coordinate product recalling system as per laws and applicable health authoritys regulations.

• Plan and implement annual product review by Fulfilling of the cGMP requirements to review production document, release data, stability product, complaints, etc., to determine trends and issues and issue a report to management on annual basis.

Scope of Responsibility:

• All ongoing operation inside manufacturing site

Organizational Relations:

• Supervision of: Compliance, Documentation, and validation sections.

• Functional relations with: Production R & D QC Warehouse-regulatory affairs- planning.

• External relations with: EDA Inspectors External Audits.

Qualifications, Necessary Skills, and Experience:

• Holds a medical background certificate : preferred Pharmacy.

• He is fluent in computers and the English language with full proficiency.

• He has the ability to speak and communicate with others.

• Analytical and planning skills.

Leadership and organizing skills.