Mostafa Mahmoud Matar

• Maintained new and transferred 14 products in accordance with compliance regulations.
• Reviewed consistency of quality planning, quality control, quality assurance and quality management system improvements.
• Worked with contracts team to review over 30 business contracts for compliance with regulatory and company requirements and negotiated over 35 technical quality agreements with contract manufacturing organization and service providers to ensure all commitments were met.
• Maintained effective working relationships with 10 regulatory authorities, 30 suppliers and customers.
• Increased company-wide awareness of relevant regulations and company standards through targeted training, presentations and ongoing communication. Worked with cross-functional teams to establish clear compliance policies and expectations for all departments.
• Worked with cross-functional teams to establish clear SOPs for all departments.
• Formulated detailed recommendations based on audit findings to support annual audit plan and target setting.
• Developed and delivered training programs to educate new and existing employees on compliance issues.
• Supported implementation of new regulations within organization by developing strategic plans and action items for each department.
• Audited CMOs and distributors (30 CMO distributors audited over last 3 years) to assess performance and effectiveness of preventive controls.
• Developed 15 effective risk assessment strategies per year to help identify areas requiring additional attention and address areas of non-compliance to maintain full regulatory compliance.
• Prepared and presented comprehensive escalation reports to senior management covering critical and major quality issues and recommended CAPA.
  Prepared records and data for regulatory and customer audits.
• Investigated 50 potential deviations, identified root cause, CAPA and reported findings to senior management.
  Evaluated 15 customer complaints and all other aspects of operations to assess compliance.
• Managed full lifecycle of 30 supplier qualification and assigned audits in line with departmental procedures, providing progress and final reports to senior management and customers.
• Managed time efficiently to complete all tasks within deadlines through change control management system.
• Performed 55 batch releases per month of locally manufactured products in accordance with company SOPs and using company ERP.
  Processed, reviewed and approved 150 deviations, CAPAs, complaints and change requests per year.
• Assessment of PQRs

Recent projects

• Implementation of TrackWise system to improve reporting of quality management system in META.
• Implementation of SAP system (quality module) in Egypt, UAE and KSA.
  Implementation of legal entity in KSA and Egypt (part of quality module).
• Site Transfer of marketed products from Acino CH site to Acino CMOs in META (Quality Module part).

• Developed and maintained TrackWise system for tracking and reporting compliance violations.
• Manage various site teams to maintain and improve quality management system and implemented effective compliance policies and procedures to meet regulatory and company requirements.
• Initiate , review and implement annual audit plan (internal & external).
• Lead site quality audit to ensure compliance with all cGMP, company and local regulatory requirements and issue relevant reports according to approved plan
• Lead auditor for 10 contract manufacturing sites according to approved plan.
• Initiate, review , Support investigation and approve over 400 change control records, deviation records, OOS records, CAPA records and PQC records and ensure that they closed on time
• Initiate, review and approve 10 TQA between company and GxP service provider
• Lead resolution of compliance and site quality index issues and other escalations through Sun Pharma Governance Model
• Ensure completion of all over 8 regulatory and CQA audit commitments and prepare responses to their observations
• Ensure that quality expenditure is within approved budget
• Execute & ensure quality index is achieved as per target and improve site quality index to above 95%.
• Ensure harmonization of over 100 site procedures to meet global global corporate standards
• Ensure delivery of corporate training programmes to over 45 site employees.
• Vendor Qualification Management and Annual Vendor Scoring for RM and PM.

Launching of over 65 New Product and site transfer

• Preparing, Reviewing, and Approving Bill of Materials: This involves ensuring that all necessary materials for production are identified and accounted for.
• Review technical files to check the feasibility of implementation e.g. manufacturing instructions, raw material specifications, analytical method and finished product specifications.
• Arranging Production of Pilot Batch/R&D Batch: This likely involves coordinating the initial production runs for testing and validation purposes.
• Reviewing and Verifying Stability Studies, Lab Files, and Registration Files: Ensuring that all necessary studies and documentation meet regulatory requirements for stability and registration purposes.
• Reviewing and Verifying Process Validation Protocol: Ensuring that the manufacturing process has been validated to meet quality and regulatory standards.
• Supporting QC and Production Team: Providing necessary support and resources to Quality Control and production teams, including reference standards and equipment.
• Approving Master Batch Records, Tablet Drawings, and Packaging Materials: Ensuring that all documentation and materials meet quality and regulatory standards before production begins.
• Approving Artwork and Specifications for Packaging Materials: Ensuring that packaging materials meet both regulatory requirements and company standards.
• Initiating and Reviewing Supplier Specifications for Packaging Materials: Working with suppliers to ensure that packaging materials meet necessary specifications.
• Reviewing Supplier Certificate of Analysis (COA): Verifying that raw materials meet required specifications as per pharmacopoeia references.

Projects

• Site Transfer of 15 marketed products from Contract Manufacturing Site to Sun Site.
• Launching of 25 new products at Toll Manufacturing sites.
• Launching of 25 new products at Sun Pharma site.
• Implementation of Track and Trace system on Egypt Site.
• Implementation of SAP System (Quality Module) on Egypt Site.

• Environmental Monitoring Reports/Trends Review for more than 15 reports per year: This responsibility involves monitoring and analyzing environmental data to ensure compliance with regulatory requirements and identify trends that may impact product quality or safety. Helping organization save costs by analyzing trends and reducing testing frequency.
• Revision of Production & Engineering Equipment Qualification Protocols (IQ&OQ): This involves updating qualification protocols for production and engineering equipment to ensure meet quality and performance standards. Help organization save costs by performing performance qualification.
• Prepare Risk Assessment for Production Machines, WTS, and HVAC, and Perform Re-qualification Plan Accordingly: Conducting risk assessments helps identify potential hazards , minimize frequency of m/c spar parts and ensures equipment meets safety and quality standards through re-qualification.
• Trends Preparation for Water Station Results: Analyzing trends in water quality data helps identify deviations ,helping organization save costs by analyzing trends and reducing testing frequency and ensure that water used in production meets required standards.
• Follow-up Implementation of Calibration System as per Calibration Plan: Ensuring that calibration systems are implemented and maintained properly is crucial for equipment accuracy and compliance with regulatory requirements and review and Approve Calibration Certificates.
• Monitoring All Process Validation Runs: Monitoring process validation runs ensures that manufacturing processes consistently produce products that meet quality standards.
• Creation of Validation Master Plans: Developing validation master plans helps ensure that validation activities are planned and executed effectively to meet regulatory requirements.
• Preparation of Risk Assessment for Hazard Products: Assessing risks associated with hazardous products helps ensure that appropriate controls are in place to mitigate risks to product quality and safety.
• Participate in Internal and External Audits: Involvement in audits helps identify areas for improvement and ensure compliance with regulatory requirements.
• Review Change Requests Report and Change Action Plans Relevant to Machines and Utilities: Reviewing change requests and action plans ensures that changes to equipment or utilities are implemented in controlled manner to maintain compliance.
• Review Investigation Reports and CAPA Actions Relevant to Machines and Utilities: Reviewing investigation reports and corrective and preventive action (CAPA) plans helps ensure that root causes of issues are addressed effectively to prevent recurrence.

Projects

• MOH license for EPCI PHARM (New Hikma Site) : Working closely with project team for obtaining MOH license. It ensured that all necessary documentation and requirements are met in timely manner.

• QA SOP Preparation and Update for Relevant Tasks: Developing and updating Standard Operating Procedures (SOPs) is crucial for maintaining consistent quality standards and ensuring that processes are followed correctly.
• Influencing Change Management Activities Related to Process Enhancements: Being involved in change management activities ensures that process improvements are implemented smoothly and effectively across all departments involved in the product lifecycle.
• Gathering Data on Integration Issues and Vulnerabilities, Reporting Findings, and Recommending Improvements: This responsibility involves identifying potential issues or vulnerabilities in processes, reporting findings, and recommending improvements to enhance product quality and efficiency.
• Process Order Revision: Revising process orders ensures that manufacturing processes are accurately documented and reflect any necessary changes or improvements.
• PQR Preparation: Preparing Product Quality Review (PQR) reports is essential for evaluating quality of manufactured products and identifying areas for improvement.
• Initiation of Master Formula and Master Batch Record: Initiating master formulas and batch records ensures that manufacturing processes are documented and standardized for consistent product quality.
• Batch Documents Review & Release: Reviewing and releasing batch documents ensures that products meet quality standards before are released for distribution.
• Maintaining Quality Management for New Materials Code on SAP: Managing quality control measures for new materials ensures that they meet established quality standards and are properly integrated into production process.
• CGMP Implementation and Monitoring: Implementing and monitoring current Good Manufacturing Practices (cGMP) ensures that production processes adhere to regulatory standards for pharmaceutical manufacturing.
• Roll-Out Manufacturing Monitoring: Monitoring manufacturing processes ensures that meet quality standards and identifies areas for improvement.
• Inspection of Water Station Performance: Inspecting water station performance ensures that water used in production meets required quality standards.
• Checking Returned Product from Market: Inspecting returned products helps identify potential quality issues and areas for improvement in manufacturing process.
• Weekly Compliance Checks for All Warehouse Activities: Conducting regular compliance checks ensures that warehouse operations adhere to regulatory requirements and quality standards.

• Provided expert guidance to project teams, ensuring that all activities were carried out in accordance with QHSE requirements
• Educated employees on hazardous waste management, emergency response and safe work practices
• Monitored workplace activities to determine compliance with safety regulations and standards
• Conducted safety audits and inspections to identify workplace hazards and deficiencies

• Served as a key liaison between Quality Assurance and other departments, facilitating collaborative efforts that led to increased product consistency and customer satisfaction.
• Enhanced team performance by providing regular training, feedback, and guidance to Quality Assurance staff.
• Evaluated team member performance against established objectives during regular reviews, offering praise for achievements or identifying areas requiring further development.
• Reported production malfunctions to managers and production supervisors.
• Led regular meetings with production staff to review performance metrics, address any concerns or challenges, and provide updates on organizational initiatives related to quality assurance.
• Provided ongoing support to direct reports, addressing concerns or questions promptly so could remain focused on their tasks.
• Monitored testing processes, test development and user acceptance testing.
• Conducted risk assessments for proposed changes in processes or materials to evaluate potential impact on product quality and ensure smooth implementation.

• Enhanced product quality by implementing rigorous testing procedures.
• Assessed products to evaluate conformance with quality standards.
• Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
• Reported problems and concerns to management.
• Performed root cause analysis to identify and resolve quality issues and defects.
• Facilitated effective communication between departments regarding quality matters, fostering a collaborative working environment.
• Inspected products and worker progress throughout production.
• Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
• Inspected items and compared against standards to meet regulatory requirements.