# Participate in preparing the company for external audits from WHO, EUROPEAN COMMISSIN, (Romania MOH) and MHRA, as a member in the team which guided the Auditors in the audit program# Supervise QA team who carry out the detailed assessment of products and their components at different stages of production.# Review all SOP(s) before approval from QA director to assure the compliance of all activities with GMP regulations and QMS to be on risky based. # Participate as Member in the Quality Risk Management committee.# Participate as a member in the company safety committee.# Provide technical assessment and validation review/approval for facility, process and standard operating procedure changes. And Participate as a member in the company validation committee. # Coordinate with HR as a technical member during the interview with the new employees.# Lead Internal Auditor, and perform internal audits# Perform an internal audit related to (cGMP, QMS, Data integrity, EMS and OHSAS) systems on all departments in plant. (Production, QC labs, R&D, Utilities, Warehouses and distribution warehouses).# Handling and Evaluate CAPA responses to assess findings for adequacy, recall procedure including dummy recall simulation.# Handling Change Control Procedure &Evaluate the impact of change & follow up change implementation and Post change evaluation# Handling of supplier qualification procedure for all (Raw material, Packaging material, Gases and outsourcing services).# Conduct all audits by visit for all vendors as a lead auditor.# Attend all qualification processes for equipments, HVAC system and Water treatment station and make sure that the annual calibration plan for all equipments, devices and balances performed.# Responsibility for the maintenance of the quality management system to be in compliance with all applicable regulations (i.e., ISO 13485, FDA requirements such as QSR 21 CFR820 prospectively).

# Responsible for QA (cGMP compliance) team for daily inspection and follow up manufacturing areas (in dispensing, manufacturing, packaging).# Training of the QA (cGMP team) and provide them with the documented quality standards as guidelines for their day-to-day work.# Assure compliance with Environmental & Safety Rules, Elements of ISO 14001 & ISO 18001 standards around the facility.# Ensure compliance with current Good manufacturing practices (cGMP) around the entire facility, Company standard Operating Procedures (SOPs), Good laboratory Practices (GLP), Good Storage Practices (GSP), authority regulations and guidelines.# Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.# Responsible of QMS documentation : - - Deviation and quality defect investigation. - Change control system. - Customer Complaints. - NCR/CAPA system - Recall system# Responsible of Supplier qualification program.# Responsible of execution committee. (Raw materials, Packaging Materials, Finished Products and Chemicals).# Performs trending analysis of deviations, CAPAs, OOS as required.# Identifies opportunities for operational improvements for both manufacturing and deviation/investigation management Quality Events# Develops and updates SOPs and Work Instructions on a continuous basis.# Keep records of quality reports, statistical reviews and relevant documentation.

# Ensuring that Quality systems are in place and are effectively managed# Permission and reviewing of BPR and checklist# Issuance of Permission for starting preparation of batches# Attendance of execution committee for (Raw Materials, Packaging Materials, Finished Products and Chemicals, Returned and Expired Goods from market).# Performs independent quality evaluation of deviation reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending.# Review the manufacturing batch records and release batches.# Responsible for the transversal operations of a production unit within a production plant (reporting to the head of manufacturing) during night shift.# Participate in the internal audit program to ensure continued cGMP compliance of all site activities.# Follow up of packaging specification of batches to be exported# Inspection on Q.C labs, Utilities and Warehouses# Calibration and maintenance follow up for all equipments and balances# Handling the Material Safety Data Sheets files (MSDS).

# teaching chemistry for Secondary School and university students.