Tamer Abdelhakam Hamed

Quality Manager in Q for Medical Device industriesFull Time

• Job Details:•Manage and responsible for all activities performed by QA and QC sector. •Manage and responsible for all activities related of internal and external “Customers or Suppliers” audits. •Supervise the conduction of the audit plans and process for all activities in the plant. •Supervise the reviewing and measuring process the efficiency and the performance of the implemented Quality Management systems. •Responsible for renewal of ISO 9001:2008, ISO 13485:2012, and CE according to MDD 93/42/EEC. •Supervise the corrective and preventive actions plan for all non-conformities (if detected), customer complaint, and internal or external audit results. •Conduct the training sessions in CAPA (corrective & preventive action) process for all employees. •Perform a representation for internal or external audit results, control of nonconforming products results and CAPA results by using various statistical analysis methods like bi chart, bar chart, parito chart…etc. •Reporting the quality management system performance and the statues of the corrective and preventive actions plans to the top management members monthly. •Preparing for management review meeting and reported minute of meetings. •Issue the Quality, Regulatory & Compliance and internal audit statistical reports for Management review meeting. •Supervise the issuance of the Risk Management file by performing the risk assessment for all products/Process including setting Risk management plan, FMEA, Quantitative and Qualitative characteristics of all devices and the Risk Review Report according to BS EN ISO 14971. •Establishing training system (training plan, evaluation of members, training procedure, and organizational charts). •GMP training and awareness of employees including the hygiene practices. •Preparing of Risk associated with the responsibilities of job descriptions. •Supervise the issuance of the quality objectives for all company sectors and their measurements. •Review and Update the company policy and objectives. •Supervise the Follow up process of CAPAs reports statues. •Supervise the Document control center activity. •Supervise the validation process such as (packaging validation, process validation….etc). •Supervise the calibration process for all devices at the plant.

QMS (Quality Management System) Lead Auditor In ALLMED Middle East for advanced Medical IndustriesFull Time

• Job Details:• Manage and responsible for all activities related of internal and external “Customers or Suppliers” audits. • Set and conduct the audit plans and process for all activities in the plant. • Review and measure the efficiency and the performance of the implemented Quality Management systems. • Participated in renewal of ISO 9001:2008, ISO 13485:2012, OHSAS 18001:2007, ISO 14001:2004, CMDCAS and CE according to MDD93/42/EEC. • Set the corrective and preventive actions plan for all non-conformities (if detected), customer complaint, and internal or external audit results. • Perform a training sessions in CAPA (corrective & preventive action) process for all employees. • Perform a representation for internal or external audit results, control of nonconforming products results and CAPA results by using various statistical analysis methods like bi chart, bar chart, parito chart…etc. • Reporting the quality management system performance and the statues of the corrective and preventive actions plans to the Quality, Regulatory & Compliance director monthly. • Preparing for management review meeting and reported minute of meetings. • Issue the Quality, Regulatory & Compliance and internal audit statistical reports for Management review meeting. • Participate in the issuance of the Risk Management file by performing the risk assessment for all products/Process including setting Risk management plan, FMEA, Quantitative and Qualitative characteristics of all devices and the Risk Review Report according to BS EN ISO 14971. • Establishing training system (training plan, evaluation of members, training procedure, and organizational charts). • Training of the new joining on QHSE system. • GMP training and awareness of employees including the hygiene practices. • Preparing of Risk associated with the responsibilities of job descriptions. • Participate in the issuance of the quality objectives for all company sectors and their measurements. • Review and Update the company policy and objectives. • Follow up the CAPAs reports statues. • Supervise the Document control center activity. • Participate in validation work as member in validation team such as (packaging validation, process validation). • Supervise the calibration process for all devices at the plant

Quality Assurance Section Head Full Time

• Job Details:• Participated MGM to be certified in the following standards; ISO 9001:2008, SA 8000:2008, ISO 14001:2004, OHSAS 18001:2007, and ISO 22000:2005 Standards. • Prepare company internal audit plan on annual basis. • Manage, maintain and improve quality documentation system. • Conduct internal audit for all company activities according to applicable standards. • Submit QMS evaluation report to quality assurance manager on a regular basis. • Participated in handling of customer complains. • Making daily audit in chemist laboratories / raw material lab and production lab and making calibration for each apparatus and gauges to make sure that it is efficiency in high level. • Monitor closely the implementation of line quality operations, good house keeping, cleaning and sanitation, validation, complaints and non conformance and corrective and preventive actions. • Review Product Condition at the various warehouses. • Work as a Resource to Solve Quality Technical Problems whenever happen. • Verifying the effectiveness of QMS through System Process Internal Quality Audit. • Coordinate with Production Engineers SPC and Process Inspection Requirement. • Ensure the thorough Implementation of the Procedures and working Instructions. • Develop, writes & updates the Internal Processes and Procedures according to the latest Quality theories and Realistic Environment Requirements. • Documenting, Submitting and maintain audit records. • Responsible of problem solving process and Quality Improvement program. • MGM became an approved supplier for PepsiCo Egypt and international, Coca Cola Egypt and International, SAB Miller, Heineken, Nestle, Heinz, Hero, Amoun Pharmaceutical, GlaxoSmithKline, Sanofi Aventis, Novartis Pharm, October Pharm and El-Hekma Pharmaceuticals.