Head of Quality
Julphar Saudi Arabia
Total years of experience :23 years, 6 Months
Responsible for overall Quality systems, compliance and culture at Company
Overall responsible for Quality compliance and culture at RB for both unit pharmaceutical and FMCG
Responsible for establishment of Quality Systems and Standards at Novartis pharmaceutical plant
To ensure the Quality of tablets and liquids Products as per GSK, local regulatory requirements.
• To implement Quality Management system of GSK
• To effectively manage the five teams with 5 Managers and 20 teams memebrs
• To ensure Stability studies and reporting as per ICH and GSK requirements
• To ensure compliance with EHS protocols and SOPs
• Carry out Performance Appraisals and Identify people for “Talent review”.
• To provide laboratory support for new product launches and change of materials etc
• Provide technical information to regulatory affairs department and review the product registration forms on “ Re-newal”
• Member of the Site Quality Council and departmental leadership team
• Member of Level 2 Auditing team at Site
• To ensure the Quality of Penicillin Products as per GSK, local regulatory requirements.
• To implement Quality Management system of GSK
• To implement the Compendium of analytical procedure (CAP) in lab.
• Manage and train the laboratory team for better efficiency
• Manage the Departmental CAPEX and OPEX budget in effective ways
• To ensure Validations (Equipments, test method and computer system), Calibration as per plan and in compliance manner
• To ensure Stability studies and reporting as per ICH and GSK requirements
• To ensure compliance with EHS protocols and SOPs
• To ensure all Microbiological testing, validation, area monitoring as per GSK and local regulatory requirements.
• Carry out Performance Appraisals and Identify people for “Talent review”.
• To provide laboratory support for new product launches and change of materials etc
• Provide technical information to regulatory affairs department and review the product registration forms on “ Re-newal”
• Member of the Site Quality Council and departmental leadership team
• Member of Level 2 Auditing team at Site
• Ensure all departmental Level 1 Audits of QMS and EHS held and reported as per Schedule
• To do Quality Comparison and Pharmaceutical equivalence study of GSK products and others local brands
• To ensure the Quality of Sterile Products as per GSK, local regulatory requirements.
• To implement Quality Management system of GSK in Injectables laboratory response for GMP, Batch release, Microbiological, Validation of sterile plant and equipments, Periodic product review etc
• To implement the Compendium of analytical procedure (CAP) in laboratory.
• Manage the Departmental CAPEX and OPEX budget in effective ways
• To ensure Validations (Equipments, Utilities, test method and computer system), Calibration as per plan and in compliance manner.
• To ensure Hazard Analysis of Critical Control Points (HACCP) of a system.
• To ensure compliance with EHS protocols and SOPs
• Provide technical information to regulatory affairs department and review the product registration forms on “ Re-newal”
• Member of Level 2 Auditing team at Site
• Ensure all departmental Level 1 Audits of QMS and EHS held and reported as per Schedule
• Member of the Site Quality Council
• To ensure Compliance with the Global Quality Assurance (GQA) audits
• To prepare CAPA and Up-date CARISMA-2 reporting for Level-3 and Level-4 audit compliance
• To prepare CAPA and Up-date CARISMA-2 reporting for Quality Alerts compliance
• To prepare Quality plan of the Site
• To Manage the Change Control process at Site
• To Manage the Deviation process at Site
• To handle the customer complaint process
• To handle the on line compliant process
• To have deployment of Quality Management system at Site.
• To do the Periodic product review (PPR) of Sterile products
• To prepare Validation master plan of the department
• To ensure/ do validation of Sterilizers ( Autoclave and Oven)
• To ensure/do DOP (HEPA integrity) testing of sterile plant
• To ensure/do Area qualifications
• To ensure/ do thermal mapping of areas, Ovens, refrigerators, clod room and AC stores etc.
• Maintain Risk log and Risk Register of the department
• To do L1 Audit of the department
• Member of the Site Quality Council
• To do Microbiological monitoring of areas and Utilities
• To do sterility test, LAL test of sterile products
• To do validation of Microbiological methods, Equipments
• To ensure GMP compliance of the Sterile department
• Sterility test (Infusion, dry powder, ampoules, vials)
• Pyrogens test by Rabbit
• Sterile area monitoring
• Bioassay
• ISO 9001 documentation
• Water testing (Purified, distilled and WFI)
Human Resources Management, Project Management, Quality Control, Quality Tools and Techniques, Finance Management, Marketing, Environment Health and Safety, Waste Management, Production Planning and Control, ISO 9001:2000, ISO 14001, SA 8000, ISO 18001, ISO 17025
Mycology, Virology, Bacteriology, Genetic Engineering, Immunology