Osama El Baz Email & Phone Number

Riyadh, Saudi Arabia

  Managing all activities of the quality control department, including raw materials, packaging materials, intermediate, finished products, validation, sampling, maintenance & calibration of laboratory instruments and microbiology laboratory as well as stability testing to ensure compendia, company and regulatory compliance.  Vendor Qualification & Dissolution profile. Responsible for daily planning, products testing and releasing by QC. Support generation of specifications for Raw materials, packaging materials and finished products in collaboration with AR&D. Prepare responses to audits, deviations, OOS, OOT, customer complaints and CAPAs. Actively works to ensure responses are completed on time. Manage laboratory equipment within QC including troubleshooting, repair, calibration and qualification. Responsible to ensure appropriate training and development plans are in place for all employees in the QC group. • Review and approve raw material, finished product and stability test data generated in the Quality Control Laboratory as required. Reviewing and approving ongoing stability programs, APR’s, dissolution profile protocols and analytical method transfer protocols& reports Generating and updating SOPs as per SFDA recommendation. Coordinated with supply chain department to develop new vendors for APIs, excipients and packaging material. Own QC budget & work on cost optimization/reduction. Lead the data integrity program compliance in QC laboratories. Lead a staff of 40 personnel. Quality Manager registered in SFDA for Riyadh pharma factory license (Quality Person Jan2018-May 2019)

Saudi Arabia

 Responsible for all activities of the quality control department, including raw materials, packaging materials, intermediate, finished products, validation, sampling, maintenance & calibration of laboratory instruments and microbiology laboratory as well as stability testing to ensure compendia, company and regulatory compliance.  Responsible for daily planning, products testing and releasing by QC. Documentation responsibilities included SOPs, specifications, and procedures and stability data review of new and existing products. Investigated customer complaints, OOS investigations and troubleshooting of manufacturing and packaging deviations. Supported manufacturing and compliance departments in investigations, process validations, deviations and customer audits. Managed initial and continuing training for lab personnel and develop employees within the Quality function to ensure an efficient and effective Quality function exists within the company. Responsible for writing and/ or reviewing method transfer protocols, reports, Certificate of analysis and SOPs relevant to QC to meet regulatory guidelines and expectations. Review and ensure the implementation of Pharmacopoeial updates

Riyadh, Saudi Arabia

 Supervision on different labs in Quality Control department (Finished product lab, Raw material lab and Instrumentation lab). Solving trouble shooting for the analytical work problems. Providing continuous improvement of QC operations within the department for GMP and GLP. To handle investigation and checking of out of specification (OOS) results. To provide all sampling, testing and analytical requirements for Quality Control department. Performing Technology transfer of analytical methods and review of the same Responsible for daily planning, product testing and releasing by QC. To be as a member of internal and external audits if it is required. Liaising with other company departments to ensure that the QC laboratories contribute to the efficient operation of the factory, and to provide technical information as required. To provide effective management for the laboratory supervisors and technicians. Pharmacopeia updating & verification for Riyadh pharma specifications and SOP.

Riyadh, Saudi Arabia

 Practicing the role of section supervisor and ensuring the overall daily performance. Implement system and documentation according to the cGMP requirements. Create and update laboratory Standard Operating Procedures (SOPs), as well as to issue Control Procedure and Worksheet for raw materials and FP. Ensure that the raw material staff conducts their work in a manner that meets GLPs and company policies. Participate in instruments Validation Master Protocols IQ, OQ and PQ of analytical instruments and performing PQ related to analytical instruments such as HPLC, GC, UV, IR, KF, TOC, Auto titrator, NIR, Dissolution, Viscometer. Carry out training activities assigned by the Head of Q.C. To take part in an internal quality audits. To participate with the environmental monitoring and water analysis. To guide the preparation of volumetric solutions and reagents. Working standards certification.  To participate the investigation of OOS. Checking of Dossiers for new products and current pharmacopoeia. Validation and verification of analytical method as per USP, BP&ICH Guidelines. To ensure that all analytical equipment and instrumentation in QC lab are fully validated and dully calibrated. To ensure that all relevant analytical Kits and Tools are calibrated. To perform the necessary periodic maintenance for analytical instruments in the QC lab. To ensure that all analytical requirements of instrumentation, spare parts and glassware are available. Initiation of purchasing request for the required needs of QC lab. Reviewing analytical documents such as: working standard qualification, specification, standard testing procedure, stability study protocol, SOP’S, glassware-cleaning validation.  Providing data to regulatory affairs for filing purpose as per the regulatory requirements and meeting the pre-decided timelines.