Country Quality Manager
DSV
Total years of experience :16 years, 11 Months
Ensure to implement QHSE Management systems across all DSV Egypt sites & locations.
Performance evaluation for the organization by monitoring, measurement, analysis and evaluation through multiple outputs like Customer feedback (quality complaints & customer surveys) - Deviations and incidents investigations - Corrective actions implementation follow up and effectiveness monitoring - Internal audits program implementation and effectiveness monitoring - Change control management - System Validations/calibration and lastly presenting theses analyses through the periodic management review and follow up the actions needed to improve these processes.
Determine and select opportunities for improvements from the multiple resources like corrective and preventive actions derived based on root cause analysis of internal incidents/accidents/deviations - Customer complaints and feedback - Internal audits observations - External audits observations - Management reviews actions and output - Global and regulatory standards update - etc.
Ensure that all resources required for the processes to run effectively are available like Trainings and competency - Clear roles and responsibilities for the different departments - updated risk assessments for important and critical processes to address strengths/weaknesses and opportunities/threats - Clear objectives/goals and consistent with organization policy/goal - Effective and clear ways of communications in the entire organization - Control of documented information (documentation).
Responsible for obtaining and maintaining all kinds of certifications and standards (ISO certificates - Good Manufacture Practice - Good Distribution Practice - etc.) by handling External audits of regulatory and certifications bodies - Qualifying departments and organization to successfully passing the audits - Approving and developing suppliers and subcontractors - Identifying training needs and competencies for the critical processes.
Accomplishes quality assurance objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, consulting and disciplining employees; communicating job expectations, planning, monitoring, appraising and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.
Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality and customer service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
Enhances department and organization reputation by applying and developing QMS.
Monitors and support other functions to achieve its improvement and cost saving targets towards with finance alignment.
Creates value stream mapping of the DC processes using MIFA (material information and flow analysis) to support process optimization, waste elimination and improvements in measures of efficiency.
Demonstrate practical experience in the use and application of CI (continuous improvement) initiatives, tools and principles.
Responsible for Determining, and approving internal quality procedures, standards and specifications.
Responsible for management review meeting and setting the most appropriate actions for discussed points.
Determine, approve, and evaluate internal training sessions (ISO 9001:2015, ISO 17025:2005, cGMP, cGLP, ICH E&Q, NRDHM, OECD GLP, and OECD TGs) to increase the effectiveness and knowledge of the company staff to be future successors.
Determining external training sessions required for all company staff.
Assessing and setting customer requirements and assuring that all are met.
Responsible for product complaints and recall activities.
Prepare, implement and approve internal audit activities.
Evaluate and participate in the approval decision of all service providers (Pharmaceutical Manufacturing Facility, Bioequivalence Centers, Clinical Research Organizations (CRO), Scientific Research Centers, Animal Laboratories, Medical laboratories and Calibration/Validation centers).
Auditing all service providers to ensure that their systems are matching with the required guidelines (ISO 9001:2015, ISO 17025:2005, cGMP, cGLP, ICH E&Q, NRDHM, OECD GLP, and OECD TGs) and in-house requirements.
Responsible for risk management regular meetings and follow up the implementations of approved actions.
Review and approve all company documents such as contracts, protocols, interim reports .etc.
Ensure the integrity and validity of all the studies and the experimental results.
Review job descriptions of all the staff.
Manage the quality team to perform the assigned tasks with the predetermined time frame.
Perform KPIs of subordinates twice/year as part of evaluation.
Prepare and follow up the monthly report for department activities.
Establishing a company's quality procedures, standards & specifications.
Reviewing customer requirements and ensuring that they are met, Setting standards for quality as well as health and safety.
Making sure the processes meet international and national standards.
Defining quality procedures in conjunction with operating staff
Monitoring performance by gathering relevant data and producing statistical reports.
Supports development of quality assurance strategies, processes, guidelines and control plans which assure quality.
Leads the initiation and follow-up of corrective action requests and preventive measures to achieve quality targets.
Investigates and addresses trends with internal and external non-conformance.
Quality & Compliance section head responsible for establishing, implementing and reviewing the quality system to ensure that processes and activities which have impact on product quality & safety follow and comply with Good Storage Practice (GSP) and Good Distribution Practice (GDP) guidelines.
Quality representative of the facility who is responsible for all aspects of quality assurance, establish the quality manual, issue, review & update work instructions and SOPs. Self inspection, follow and maintain Good Storage, Warehousing, Distribution Practices, (GSP), (GWP) and (GDP) guidelines.
Quality supervisor lead a team to perform In Process Control operations and check following GMP guidelines.
responsible for Sampling of semi-finished products and finished products for each batch to obtain representative samples, Observes conditions on line and in-process area for compliance with the process method, for correct operation of procedures and for cleanliness and clearance of other components, Ensures production materials meet defined quality standards prior to disposition and responsible for tracking and trending of out-of-specification results, failure investigation, nonconformance, deviations, change controls and complaints.
Work experience as an instruments lab analyst (Central Lab) from June 2008 till June 2009 in the Quality Control sector of (CID) Chemical Industries Development Company working on many instruments such as HPLC, Karl Fischer, UV, Infra Red and GC
Sampling of semi-finished products and finished products for each batch to obtain representative samples, Observes conditions on line and in-process area for compliance with the process method, for correct operation of procedures and for cleanliness and clearance of other components, Ensures production materials meet defined quality standards prior to disposition and responsible for tracking and trending of out-of-specification results, failure investigation, non conformance, deviations, change controls and complaints.
Semester 1 "Mandatory Courses" Contemporary Management Quality Assurance Concepts and Systems Statistics for Management Decisions Competing in a Global Environment ..... Semester 2 "Mandatory Courses" Statistical Quality Control Management Information Systems Quality Management Research Methodology ...... "Elective International Certificates" (Practical experience) Green Belt Lean Six Sigma Information Security Management System (ISO 27001) Quality Management System (ISO 9001) Food Safety Management System (ISO 22000) Bronze Lean Enterprise Certificate ..... Semester 3 "Mandatory Courses" Group Dynamics Customer Relationship Management Thesis part 1 ...... "Elective International Certificates" (Practical experience) British Retail Consortium (BRC) Environmental Management System (ISO 14001) Energy Management System (ISO 50001) Occupational Health & Safety (OHSAS 18001) ..... Semester 4 "Mandatory Courses" Advanced Topics in Quality Management Business Process Re-engineering Thesis part 1 ...... "Elective International Certificates" (Practical experience) Certified Professional Healthcare Quality (CPHQ)- Part (1) NEBOSH-Part (1) Certified Professional Healthcare Quality (CPHQ)- Part (2) NEBOSH-Part (2)