Abdulrhman Hawari

Develop and implement validation strategy: This strategy defines approach to validating equipment, processes, cleaning procedures, and computer systems used in manufacturing. It ensures compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.

• Manage staff and workload: This involves leading validation and calibration team, assigning tasks, providing coaching, and ensuring have necessary skills and resources.
• Oversee validation projects: This includes planning, executing, and documenting validation activities for equipment, processes, and cleaning procedures.
• Manage calibration program: Manager establishes program for calibrating instruments and equipment at defined intervals to ensure their accuracy. This involves coordinating with external calibration service providers if needed.
• Develop and maintain validation and calibration procedures: These procedures define steps for conducting validations and calibrations consistently and effectively.
• Ensure compliance with GMP and other regulations: stays updated on regulatory requirements and ensures the department's activities adhere to them.
• Maintain validation and calibration documentation: This involves creating, reviewing, and approving detailed documentation for all validation and calibration activities.
• Prepare reports for management and regulatory agencies: generates reports summarizing validation and calibration activities and their outcomes. These reports demonstrate compliance and support quality control efforts.
• Manage change control processes: When there are changes to equipment, processes, or computer systems, manager ensures proper validation and calibration activities are conducted to maintain product quality and safety.
• Investigate deviations and non-conformances: Manager leads investigation of any issues identified during validation or calibration activities and takes corrective actions to ensure continuous improvement.
• Maintain communication with other departments: Validation and calibration department interacts with various departments like production, engineering, and quality assurance. manager fosters effective communication and collaboration to ensure a smooth and compliant manufacturing process.
• Prepare departmental budget: Estimating costs, Justifying expenses, Obtaining approval, Monitor and manage budget.
• Resolved conflicts proactively by facilitating open communication among team members and actively addressing underlying issues.
• Enhanced team productivity by implementing efficient workflow processes and providing consistent guidance.
• Recruited, hired and trained staff and provided ongoing feedback and performance evaluations for development.

• Site Master File, Contract Manufacturing & Analysis System, Annual Product Review, Batch Records Control (Issue, Review, Archive, etc.), Training System, Quality Risk Management, Personal Hygiene & Health Check System, Quality Objectives & Quality Planning System, Internal & External Auditing System, Supplier/Lab./Center Auditing System, GMP compliance internal inspection system, Product Complaints, Recalls and Returns, Change Control System, Handling of Waste and disposed materials, Supplier Selection & Evaluation System, Rodent & Pest Control System, Gowning system, IPC System (In-Process Control Lab), CAPA (Corrective / Preventive) System, Qualification File Review (DQ, IQ, OQ and PQ), Cleaning Validation (protocol, matrix, etc.), Process Deviations & Incidents (Root Cause Analysis), Quality Management System, Process Validation (Protocol, Report), Documentation System (control of Document, Control of Record, Distribution, etc.), Responsible to Follow up all activity related to Quality System.

• Site Master File, Contract Manufacturing & Analysis System, Annual Product Review, Batch Records Control (Issue, Review, Archive, etc.), Training System, Quality Risk Management, Personal Hygiene & Health Check System, Quality Objectives & Quality Planning System, Internal & External Auditing System, Supplier/Lab./Center Auditing System, GMP compliance internal inspection system, Product Complaints, Recalls and Returns, Change Control System, Handling of Waste and disposed materials, Supplier Selection & Evaluation System, Rodent & Pest Control System, Gowning system, IPC System (In-Process Control Lab), CAPA (Corrective / Preventive) System, Qualification File Review (DQ, IQ, OQ and PQ), Cleaning Validation (protocol, matrix, etc.), Process Deviations & Incidents (Root Cause Analysis), Quality Management System, Process Validation (Protocol, Report), Documentation System (control of Document, Control of Record, Distribution, etc.), Responsible to Follow up all activity related to Quality System.

• Supervise the activities of documentation section performed by documentation officer & Batch & Product Review
• Prepare documentation requirements for internal or external auditing and inspection.
• Preparation of documentation activity reports in monthly and yearly
• Internal Auditing
• Review daily/weekly inspection Report prepared by Supervisor and officer Prepare suitable training programs and needs for employees in inspection & documentation.
• Follow up final finished product release, customer complying, or any non-conforming report.
• Follow all department staff (daily report, non-conforming case and division of work among themselves).
• Follow batch record review and annual product review.
• Follow up cleaning validation report and process validation report.
• Follow up artwork (making code and final approval).
• Perform SAT (Set Acceptance Tests) for all Manufacturing & Packaging Machines.
• Perform cleaning validation (Calculate surface Area, create sample planning, taken sample from Machine and Equipment and follow up after Validation of Machine & Equipment).
• Perform Performance Validation (PQ), Operation Qualification (OQ), and Process Validation.
• Make code for Artwork Design and follow up to Final Approval as per Specification.

• Quality Assurance Compliance in Warehouse and Production,
• Batch Record Final Review.
• Inspection of Finished products.
• Maintained quality in manufacturing area and warehouse.
• Finished products release.