Experience

NewBridge Pharmaceuticals

• United Arab Emirates
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regional Quality Assurance Manager

  • Aug 2017 - Present

  The key purpose of the role is to manage the development, implementation and maintenanceof an efficient quality management system tackling mainly all GxP and health-regulatedactivities related to storage, distribution and commercialization of health care goods and theirassociated services and solutions, while meeting business objectives. Fruther, the QAManager manages product complaints and quality events and coordinate quality alertmanagement, as local focal point at NBP level; and provides quality leadership across the NBPorganization, with a priority focus on activities pertaining to quality of products, informationand services.



Medpharma - Valeant int. Pharma.and Chem. industries .

• Quality Assurance Manager.

  • Nov 2010 - Present

  - Design, develop & implement Quality Management System (QMS) as per GMP.- Prepare site master file (SMF), Quality Manual, Approve SOPs & Quality documents- Ensure that quality systems meet regulatory requirements, marketing authorization - Training – Oversee cGMP & total quality management (TQM) aspects - Audit - Plan, lead internal audit (self-inspection) as per audit program. Approve compliance plan- Inspections - Host inspection authority follow up on findings - CAPA –Take corrective & preventive actions (CAPA) for continual improvements- Lead Quality related Investigations, failures & out of specifications (OOS)- Quality Review – Undertake product quality review (PQR) & management review (MR)- Change Management - take decision on change control proposals (CCP)- Deviation Control - Review, approve / reject planned & unforeseen deviations- Perform Vendor qualification / Supplier assessment- Complaints - Evaluate & investigate product complaints - Approve validation master plan (VMP). Undertake FAT, DQ, IQ, & OQ & PQ. - Perform Utility qualification like purified water, compressed air& HVAC.- Ensure calibration of measuring instruments & devices as per calibration program & policy- Manage Process validation, cleaning validation



Medpharma-UAE

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• production manager

  • May 2003 - Nov 2010

  • To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.• To review & approve the instructions relating to production operations and to ensure their strict implementation.• To ensure that the production records are evaluated and signed by an authorized person (him or his delegate) before they are sent to QA department.• To check the maintenance of his department, premises & equipment. To ensure that the appropriate validation are done• To make sure that all instruments and equipment used in production are regularly calibrated.• To participate in the on-going internal audit program and take the necessary corrective action against any points highlighted by the audits tested and results documented• To ensure that the required initial and continuing on job training of his department personnel is carried out and adapted according to need.• To ensure proper handling of materials intermediates products, and finished goods, such as receipt, labeling, storage, dispensing, processing, packaging, quarantine and delivery, and that these operations are performed against written procedures.• To assign the duties and responsibilities of all production personnel, and to evaluate and document their performance on regular basis.• To revise production operating procedures and to ensure their strict implementation.• To set the monthly production program in collaboration with the planning department.• To check production yields and to perform any necessary reconciliation.• To establish a proper hygiene program to prevent cross contamination and to observe that it is followed by all production personnel. This program should include approved procedures relating to hygiene, health, and gowning of personnel.