Peter Nagy Email and Phone Number
Seeking for a new challenge through which, my professional background, personal skills and experience can be applied, developed, improve, and challenged.
Soficopharm
View- Website:
- soficopharm.com
- Employees:
- 88
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Quality ManagerSoficopharm Oct 2020 - PresentEgypt1. Rsponsible for development, implementation and monitoring of the Quality System. ISO 9001: 2015, ISO 45001: 2018, ISO 14001: 2015.2.Review Quality agreements with external partners suppliers.3.Manage quality processes and reports - suspect products, damage products Recall, complaints Maintain relationships with suppliers.4.Manage and implement requirements from Suppliers, customer and internal sources as input for new process or problem solving.5.Contribute to new business initiatives and projects, and communicate the impact on Quality Management Systems and GSP, GDP.6.Work as part of the Management team to improve operations and ERP system.7.Develop and deploy a standardized inventory handling and control process across all locations and ensure the effectiveness of the implementation.8.Create, Manage and monitor a measurement for process and review of internal processes, that affect the quality management system and GSP, GDP.9.Update documented information described in the Quality Management System and communicate to carry forward lessons learned from quality concerns.10.Report to top management on the performance of the IMS , GSP, GDP including the need for improvement.11.Monitor, create and report on Key Performance Indicators (KPI's) for each Area Ensuring that are met.12.Using six sigma and lean six sigma as an improvement tool besides statistical analysis for the performance of the process using Statistical tools.13.Train in all aspects of the quality system, and application of procedures.14.Liaise with external bodies on all matters relating to registration and recertification for ISO 9001, 14001, 45001and supplier visits. 15.Ensure that all documented information are updated, revised and modified to meet the needs of GSP, GDP regulation, external certification bodies and Verify closure of non-conformities with Certification Bodies.16.Conduct risk assessments of all processes. -
Quality / Gxp InstructorOps For Business Consulting Apr 2022 - PresentCairo, EgyptQuality Management courseGXPRisk assessment coursestrategic management course ASQOrganization structure course ASQManagement philosophy course ASQInternal Audit courseICHQ 10,9,8ISO 9001 | 14001 | 45001 -
Business InstructorValor Egypt Mar 2021 - PresentCairo, EgyptQuality Management courseGXPRisk assessment coursestrategic management course ASQOrganization structure course ASQManagement philosophy course ASQInternal Audit courseICHQ 10,9,8ISO 9001 | 14001 | 45001 -
Quality Management System ManagerAlfacure Pharmaceuticals Aug 2019 - Sep 2020Egypt1. Contribute to the creation and implementation of best practice capacity planning vision, functional strategy, policies, processes and documented information to aid and improve operational performance.2. Contribute to new business initiatives and projects, and communicate the impact on Quality Management Systems and GMP.3. Design Quality Processes throughout the manufacturing operation, and monitoring the quality performance and GMP.4. Create, Manage and monitor a measurement for both process and product, and review of internal processes, especially those that affect the quality management system and GMP.5. Update documented information described in the Quality Management System.6. and communicate to carry forward lessons learned from quality concerns.7. Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), GMP including the need for improvement.8. Monitor, create and report on Key Performance Indicators (KPI's) for each Area Ensuring that are met by working to the overall plan, including management.9. Using six sigma and lean six sigma as an improvement tool.11. Keep up on new standards, regulations/laws, issues, GMP and news respect to product quality.12. Lead auditor for ISO 9001, 14001and 45001.13. Train others in all aspects of the quality system, and application of procedures.14. Liaise with external bodies on all matters relating to registration and recertification.15. Ensure that all documented information are updated, revised and modified to meet the needs of GMP regulation, external certification bodies and Verify closure of non-conformities with Certification Bodies.16. Ensure that all necessary systems and documented information are in place to satisfy all customer requirements and audits.17. Provide detailed statistical analysis.18. Ensure that the function operates in accordance with QHSE standard.19. Conduct risk assessments of all processes. -
Quality Assurance ManagerAlfacure Pharmaceuticals Apr 2019 - Aug 2019Egypt1. Create QHSE Objectives according to external and internal polices, follow up action plans to maintain the continuous improvements.2. Create and update SOP and work instructions for QHSE, GMP.3. Established key process indicators (KPI’s) and implemented CAPA to eliminate the root causes of poor quality and delivery problems.4. Implement, Communicate and Follow up the GMP and QHSE requirements through KPIs. 5. Monitoring daily performance for QHSE by gathering relevant data and producing statistical reports.6. Conduct GMP and HSE training in a daily bases according to training plan for different levels supported by On Job Training. 7. Implement, maintain and follow up the management review. 8. Develop, implement and maintain audit plan to conduct internal audits according to ISO 9001, 14001, ISO 45001 and GMP.9. Lead the surveillance audit from external vendors and regulatory visits as a quality representative and following up the actions.10. Vendor evaluation and qualification for packing and raw materials.11. Prepare daily, monthly and yearly reports about the status of GMP, QHSE overall department contain the needs for improvement.12. Develop, implement and maintain OQ and PQ protocols for devices and machines.13. Create and update Site Master File and Validation Master Plan.14. Implement, maintain process, cleaning validation and Hold time for different products.15. Monitor, maintain Area qualification including HVAC.16. Conduct risk assessment in daily basis for every place and implement an action plans for every issue.17. Prepare calibration plan (External and Internal calibration plan).18. Create, review and release Master Batch record.19. Preparation of Annual Product Review.20. Handling of Market complaints and out of specification. -
Quality Assurance Section HeadFresenius Medical Care Oct 2015 - Apr 2019Egypt1. Maintain, develop and follow up Quality objectives, achievements and performance improvement throughout the organization using statistical tools, lean six sigma under the Quality policy umbrella.2. Ensuring the execution of SOP and work instructions for QHSE, GMP and GLP.3. Monitor and follow up the execution for corrective action and preventive action for different departments4. Implement, Communicate and Follow up the GMP requirements through KPIs. 5. Monitoring daily performance for QHSE by gathering relevant data and producing statistical reports.6. Conduct GMP, GLP and HSE training in a daily bases according to training plan for different levels. 7. Internal Auditor for GMP, ISO 9001, 14001, 13485 and OHSAS 18001. 8. Implement, maintain and follow up the management review, its review and follow up inputs and outputs in a raw. 9. Develop, implement and maintain internal audits for ISO 9001, 14001, 13485 and OHSAS 18001.10. Lead the surveillance audit (Internal / External) as a quality representative for three factories and following up the actions.11. Prepare monthly and yearly reports about the status of GMP, QHSE overall department contain the needs for improvement.12. Develop, implement and maintain IQ and OQ for devices and machines13. Conduct risk assessment in daily basis for every place and implement an action plans for every issue.14. Work with different departments in setting up SOP and work instructions 15. Prepare calibration plan (External and Internal calibration plan).16. Prepare and maintain a clean room file for different areas.17. Create, review and release batch record.18. Check different process thought IPC and check list -
Quality Assurance ManagerUnivest Group Apr 2014 - Oct 2015Egypt1.Develop, implement, communicate, follow up and maintain the Quality Health ,Safety and Environmental quality plans, Quality Systems , Quality Objectives and Policies2.Maintain Quality achievement and performance improvement throughout the organization using statistical tools3.Ensuring the execution of corrective action and preventive action in QHSE and GMP4.Implement, Communicate and Follow the GMP requirements. 5.Monitoring daily performance for QHSE and GMP by gathering relevant data and producing statistical reports.6.Conduct GMP training in a daily bases according to training plan. 7.Setting up and maintaining controls and documentation procedures.Internal Auditor for GMP ISO 9001, 14001and OHSAS 18001 , 8.prepare for time meeting understand the requirements of other departments9.Implement, maintain and follow the management review and it’s outputs. 10.Develop, implement and maintain Audit Check List in order to check on the various departments11.Prepare daily, monthly and yearly reports about the status of GMP, QHSE overall department contain an assessment and the needs for improvement12. Prepare the budget for QHSE department every year 13. Conduct risk assessment in daily basis for every place and implement an action plans for every issue14.Conduct Job Safety Analysis for every activity and reviewed in daily basis Work with production in setting SOP, Batch Record and prepare IPC work instructions documents.15.Prepare calibration plan (External and Internal calibration plan) -
Senior Quality Assurance EngineerFranke May 2012 - Apr 2014Egypt1.Develop, implement, communicate, follow up and maintain the Quality Health ,Safety and Environmental objectives 2.promoting safety achievement and performance improvement throughout the organization using statistical tools3.Ensuring the execution of corrective action and preventive action in QHSE4.Monitoring daily performance for QHSE by gathering relevant data and producing statistical reports.5. Conduct QHSE training in a daily bases according to training plan 6.Setting up and maintaining controls and documentation procedures.7.Internal Auditor for ISO 9001, 14001and OHSAS 18001 , 8.prepare for time meeting understand the requirements of other departments9.solving problem and improve the systems10.Develop, implement and maintain Audit Check List in order to check on the various departments11.Prepare monthly report about the status of QHSE overall department contain an assessment and the needs for improvement12.Prepare the budget for QHSE department every year 13.Conduct risk assessment in daily basis for every place and implement an action plans for every issue14.Conduct Job Safety Analysis for every activity and reviewed in daily basis -
Assistant Quality Assurance ManagerSpice Kingdom Nov 2009 - Apr 2012Obour1.Develop, implement, communicate and maintain a quality plan to bring the Company’s Quality Systems and Policies into compliance with quality system requirements2.promoting quality achievement and performance improvement throughout the organization using statistical tools & Lean six sigma 3.ensuring the execution of corrective action and compliance with customers' specifications; 4.Monitoring performance by gathering relevant data and producing statistical reports.5.persuading reluctant staff to change their way of working to incorporate quality methods6.ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary7.identifying relevant quality-related training needs and delivering training8.Setting up and maintaining controls and documentation procedures.9.Internal Auditor for ISO 22000 ,HACCP and BRC10.prepare for time meeting understand the requirements of other departments , solving problem and improve the systems11.Maintain and implement HYGIENE plans and food safety 12. Develop, implement and maintain KPI's13. Identify pesticides certificates according to the customers need's14. Develop, implement and maintain Audit Check List in order to check on the various departments15. Review packaging materials and implement supplier audit 16. Prepare weekly report about the status of the Q.A department, people and overall department contain an assessment and the needs for improvement17. Check the reconciliation of the lots identify the rework and scrap time and goods from the lot setting the preventive actions -
Quality AssuranceMarcyrl Pharmaceutical Industries Apr 2007 - Nov 20091.Monitors deviations from GMP in production and warehouse and reports there deviations as monthly report & for calculation performance measurement.2.Work with production in setting SOP, Batch Record & production improvement and prepare IPC documents.3.Receiving complaint and work with production in investigation and prepare the final report.4.Monitors and inspect the rework batches.5.Review of manufacturing & packaging records, cleaning & environmental control records and reports his comments to Q.A. manager.6.Checks and monitor calibrations & implements calibration plan & performs calibration of equipment( e.g. balances)7.Checks the use of components against the bill of materials8.Takes samples of the raw materials and intermediates and finished products, for release testing , stability and retention , inspect and sampling of returned goods9.Observe there execution of corrective and preventive action, incident report and NCR effectively.10.Quality Auditor ISO 900111.Observes the effectiveness of control of procedures and in process checks performed by production staff12.Follow up of utilities like water station and HVAC 13.Checks overprinted details for correctness and readability In process Control in:•Wet And Dry Granulation, Tablet Compression, Tablet Coating. •Capsule Filling. •Blistering Process.•Syrup & Semi-Solid Dosage Preparation & Filling.•Suppository Filling & Preparation. •Packaging Process and sampling •get rid of reject material•Dispensing unit•Labeling the Hold and Released Labels in hold and released unit.•Cleaning process and line clearance for (solid, semisolid, syrup and suppository ) all stages of manufacture •Internal Auditor for ISO 9001 -
Quality AssuranceEva Pharma May 2006 - Apr 2007In process Control in:•Checking the quality of all Packaging Lines in EVA Pharma (Solid , Semi Solid , Liquid)•Checking the Hold and Released Labels in hold and released unit.•Checking the quality of Printing unit (Batch no, Mfg.D, Exp.D …etc) •Inspection the quality of Dispensing Unit and operation.•Sampling•documentation: Annual Files
Peter Nagy Education Details
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Ain-Shams University, Faculty Of ScienceGood -
Business Administration -
Tabary El HegazThanawy Ama -
Menoufia UniversityBusiness Administration And Management, General
Frequently Asked Questions about Peter Nagy
What company does Peter Nagy work for?
Peter Nagy works for Soficopharm
What is Peter Nagy's role at the current company?
Peter Nagy's current role is GXP | TQM | CQM | CSSGB | MBA | DBA | Lead Auditor ISO 9001 | 45001 | 14001.
What schools did Peter Nagy attend?
Peter Nagy attended Ain-Shams University, Faculty Of Science, The Arab Academy For Management, Banking And Financial Sciences, Tabary El Hegaz, Menoufia University.
Who are Peter Nagy's colleagues?
Peter Nagy's colleagues are Mohamed Elsayed, Ahmed Yousef, Antoinette Rabbat, Aya Yehya, Rahma Raafat, Duaa Elaraby, Emil Tharwat.
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Peter Nagy
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