Quality Associate and Lead Auditor
MERSACO S.A.L
Total years of experience :16 years, 3 Months
Enhancing the Quality Management System at MERSACO S.A.L, through the effective implementation of national and international Good Storage and Distribution Practice guidelines:
• Ensure that storage and distribution operations are done according to GSDP guidelines
• Ensure that storage conditions are maintained in all MERSACO storage areas by checking the temperature monitoring reports and following up on alarms and temperature excursions.
• Prepare the yearly Quality Activity Plan and follow up on its execution in a timely manner.
• Prepare the Annual Quality Audit Plan based on priority and risk assessment.
• Conduct internal quality audits as well as second-party audits on sub-contractors; prepare audit reports.
• Conduct on-site quality inspections and issue quality inspection reports.
• Coordinate Suppliers' external quality audits and visits.
• Follow up on responding to and develop CAPA for internal and external audit observations. Ensure that CAPAs are closed out in a timely manner and resolved to suppliers' satisfaction.
• Enforce compliance with internal policies and procedures to ensure that established quality and process procedures are being followed by the appropriate personnel at all times.
• Develop and implement SOPs for compliance with MERSACO QMS and GSDP guidelines and suppliers requirements.
• Revise internal documents and check their content against internal policies, contracts and quality agreements with suppliers, GSDP guidelines etc.
• Prepare due diligence and quality agreement with MERSACO subcontractors.
• Handle the change control system. Coordinate with different departments in order to establish proper risk assessment for major and critical changes as well as the proper action plan and follow up on the implementation of the change controls.
• Handle the deviations' management system. Assess the risk of major and critical deviations on products' quality and on the QMS. Evaluate the CAPA and make sure that they are properly implemented for the continual improvement of the QMS. Report deviations to suppliers.
• Review draft quality agreements with suppliers before final approval.
• Prepare the Annual Training Plan (ATP) related to the Quality Department.
• Provide quality compliance training as per the ATP and when needed.
• Provide quality induction trainings for new recruits (QMS / GSDP / How to handle cytotoxic products / personal hygiene and grooming etc...)
• Prepare and collect data for the management review meeting including key performance indicators.
• Manage product quality complaints and report to suppliers according to agreement.
• Make sure that MERSACO warehouses, cold rooms and critical equipments are adequately qualified and validated by reviewing mapping and qualification reports.
• Prepare qualification protocols for passive transportation materials such as thermo-boxes and cooler bags.
Enhance the Quality Management System set at Benta S.A.L, contribute to the achievement of the company’s goals and objectives through the effective implementation of the quality standards and processes and assure that GMP standards are adequately applied by all units.
Major Responsibilities:
1.Delegated as Quality Assurance Manager.
2.Responsible for maintaining the quality system documentation.
3.Handling all quality assurance activities as per policies and procedures.
4.Ensuring that the quality system is well respected and maintained in conformity with ISO 9001 standards and Good Manufacturing Practice standards.
5.Heading the investigation of deviations, out of specifications, change controls, complaints and improvement actions and following up the action plan set after these investigations.
6.Sending complaints to suppliers when required.
7.Preparing the Annual Internal / Quality Audits Plan and following them yearly with the internal auditors.
8.Conducting quality audits and internal audits as per the audit plan.
9.Leading external audits conducted by external auditors (from MOH / Sanofi aventis / Certipharm / TUV Hellas...) and preparing appropriate action plans.
10.Preparing the internal Annual Training Plan and following it up with concerned trainers.
11.Writing and re-evaluating quality assurance documents.
12.Reviewing Benta S.A.L internal documents before final approval
13.Preparing the management review meeting.
14. Ensuring that quality assurance inspections are done during the whole manufacturing processes
15.Performing trainings (ISO 9001, GMP, procedures, working instructions…) when needed.
16. Approving materials / products specifications.
Handling the Quality Management System in all Khoury Home branches according to the ISO 9001:2008 Standards:
•Update processes & procedures and write new ones
•Prepare an audit plan, train new auditors and set up an internal audit on all the company's processes
•Participate in meetings with the Operations Manager and prepare minutes of meetings
•Receive all the customers' complaints, resolve them immediately and prepare preventive actions in order to reduce them and keep our clients satisfied
Enhance the performance of the hospital:
•Search for Medical Administration policies and procedures to be implemented by the Medical Staff
•Develop General and Department Specific Rules and Regulations for the Medical Staff
•Prepare the Terms of Reference for all the Hospital's committees
•Organise the Risk Assessment of each department
•Revise the accreditation standards of the Occupational Health and Safety department and update them
Assisting the QSE (Quality, Safety and Environment) manager as well as enhancing the Environmental Management System (EMS) at the SLCB (Société Libanaise du Ciment Blanc) in order to get the ISO 14001:2004 certificate:
•Establish operational control instructions and implement them at the SLCB,
•Organize quality, safety and environmental surveys, set up awareness plans and train all personnel on the principles of Environmental and Quality Management Systems at Holcim,
•Prepare the Holcim environmental performance in compliance with Decree 191/1 of the MOE: Environmental Directive for Cement Factories,
•Carry out internal audits and develop a detailed internal audit plan,
•Participate in Management Review meetings,
•Assist the QSE manager in supervising corrective actions and their completion on time.
Helping the Hospital get the Accreditation under the supervision of HAS Experts (Haute Autorité de santé):
•Prepare the auto evaluation of the Hospital according to the Accreditation Standards,
•Set up action plans for each department according to the expert’s demand,
•Establish procedures and work instructions and implement them within the departments,
•Draft the mission and the vision of the Hospital,
•Participate in meetings with the Hospital’s Board of Directors.
Training in quality control on the Packaging Chain and on the Production line:
•In charge of the packaging chain; controlling samples and finding non-conformities,
•In charge of testing raw materials before and after roasting.