Mohammed Faisal El Zanaty

Experience

• 

  DEEF Pharmaceutical Industries Co.

  May 2008 - Nov 2015

  • Lead the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, and goals• Responsible for setting strategy direction for the Quality Assurance Dept. and team• Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support• Support team by guidance and coaching and provide direction/approval of activities and decisions• Cultivate and reinforce appropriate group values, ethics, norms, and behaviors• Share oversight to individuals and team on personal development, performance, and quality related issues. • Ensure proper use of assets, budget, and personnel and communicate effectively with key customers and partners, both within the site and outside as appropriate• Responsible for supporting all planned and unplanned manufacturing and labs deviations, review and approval of product and equipment change controls • Maintain the structure to ensure that all quality commitments and timelines are tracked and met. In addition, assist the senior leaders at the site in resource and budget preparations• Responsible for driving process improvements within Drug Substance, Drug Product, Site support systems• Actively with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues• Coordinate planned and/or ad-hoc external audits and drive Internal Audit plan and share reports and outcome to the Site Management Team proposing continuous improvement action plan• Responsible for driving cross-training across Site staff resources• Work directly with internal and external customers to assure Best-in-Class expectations for quality• Analyze trends, quality metrics and other data to identify quality and compliance gaps Show less • Devise procedures to inspect and report quality issues• Monitor all operations that affect quality• Supervise and guide inspectors, technicians and other staff• Follow-up development of the method of analysis of new drug molecules suitable for routine work of QC• Development of stability-indicating assay of pharmaceutical products• The validation of all the developed methods of analysis• Solving any problems encountered in all the developed methods of analysis• Performing analysis in the (accelerated and long term) stability testing of R & D batches• Analysis of formulation trials performed in the Formulation section• Responsible for compliance with a quality integrated system for quality, environment, health, and safety in relation to his job and duties• Comparative in-vitro analysis required for R & D trials• Lead activities further to analytical method to develop new or enhanced methods of analysis• Take the lead in transforming business objectives into research practice and accordingly plan and delivers results of that association• Research and hence create new analysis method of products to be registered and launched in accordance with regulatory requirements and quality assurance systems Show less • Follow-up development of method of analysis of new drug molecules suitable for routine work of QC.• Development of stability indicating assay of pharmaceutical products.• The validation of all the developed methods of analysis.• Solving any problems encountered in all the developed methods of analysis.• Performing analysis in the accelerated stability testing of R & D batches.• Analysis of formulation trials performed in Formulation section.• Responsible for compliance with quality integrated system for quality, environment, health and safety• Make recommendations for improvement• Create training materials and operating manuals Show less • Prepares Stability Reports for FDA Annual Reports and Annual Product Reviews.• Prepares Stability Protocols for Annual and Special Studies.• Monitor and performs trending for stability studies using statistical tools as appropriate.• Prepares Change Controls and Investigations as required in support of the Stability Program.• Participates in Change Control Review Board and assess changes impacting product stability• Performs annual lot tracking and coordinates with appropriate departments the selection of stability samples.• Reviews and approves stability data based on product trending.• Assist the Stability Technician in sample pulling as required. Show less

  • Quality Assurance Manager

    Sept 2012 - Nov 2015

  • Quality Control Stability Section Head

    Aug 2010 - Aug 2012

  • Quality Control Stability and Methodology Senior Specialist

    Aug 2009 - Jul 2010

  • Quality Control Stability Specialist

    May 2008 - Jul 2009
• 

  Pharco Corporation

  Feb 2016 - Jun 2017

  Production Manager

  Responsibilities• Liaise with other managers to formulate objectives and understand requirements• Estimate costs and prepare budgets• Organize workflow to meet specifications and deadlines• Monitor production to resolve issues• Supervise and evaluate performance of production personnel• Determine amount of necessary resources• Approve maintenance work, purchasing of equipment etc.• Ensure output meets quality standards• Enforce health and safety precautions• Team Leader for Risk assessment, root cause analysis and Management.• Responsible for Quality Management System (ISO 9001-2015)• Team leader for continual improvement plan• Report to upper management Show less

• 

  Leven Cosmetics

  Oct 2017 - Mar 2022

  QHSE Senior Manager

  • Developing, implementing and maintaining quality, health, safety and environmental systems within legal guidelines and standards• Ensure compliance with legislation and regulatory requirements and establish action plans to communicate them to team members• Manage internal and external quality, health, safety and environmental audits• Develop training and awareness plans for QHSE requirements• Ensure compliance with health and safety regulations• Implement procedures to control and audit QHSE processes and systems• Develop and maintain procedures to improve QHSE performance and competence• Establish objectives and action plans to achieve QHSE results• Manage incidents and accidents and implement prevention plans• Prepare reports on QHSE performance and present them to stakeholders• Provide advice and information to other departments and members of the company on QHSE issues Show less

• 

  Sabaa Pharmaceuticals

  Mar 2022 - now

  Quality Assurance Quality Control Manager

  • Encompassing both quality control (QC) and quality assurance (QA) functions• Provide quality oversight, guidance and create, monitor, implement a quality system• Ensuring operations associated with all systems are appropriately planned, approved, conducted, and monitored• Evaluating manufacturing process performance against specifications and limits to promote the quality and process improvement• Ensure that laboratory investigation reports and deviation reports are investigated and meaningful correct/preventive actions proposed as established in the current procedures• Ensure that analytical equipment is maintained and calibrated accurately and timely in accordance to site procedures and regulatory requirements.• Review, revise and maintain laboratory procedures, instructions, methods to ensure compliance with regulatory, Quality Management Systems (QMS), Analytical Technical Standards (ATS) and pharmacopoeia.• Assure all areas of responsibility are operated according to all safety regulations, procedures and expectations• Conduct effective training for quality team• To lead and delivery improvement initiatives/projects to improve operational efficiency and performance• To manage investigation of non-conformities in determining root causes and recommend and coordinate appropriate corrective actions to quality problems in conjunction with other departments• Ensure the implementation, ongoing monitoring and reporting of Key Performance Indicators (KPls) and Key Quality Indicators (KQls) that drive continual improvement QC and QA organization• Support and maintain quality systems such as investigations, deviation management, corrective and preventive actions (CAPAs), instrument qualifications and change management system• Provide oversight for administration of the training and document management systems• Participate in and take a leadership role with respect to management team initiatives and objectives Show less