 Responsible for follow up different analytical testing& validation according to the current guidelines and international standards Responsible for applying& supervising the quality documents and SOPs regarding analytical operations and working activities Responsible for following the conducted investigations in case of variations and/or Out of specification results and establishments of the non-conforming reports with the right corrective actions Responsible for following up the qualification and maintenance activities of instruments Co-operate with the registration department in all registration activities and documents. Review and approve all testing activities done in subcontracted labs. Plan the ongoing stability studies for the product range of HanzaMedic

 Involve planning and managing all aspects of the study. Manage and lead a cross functional team to successfully conduct the clinical study. Ensure effective project plans are in place and operational for each study in accordance with applicable project plans, center procedures (SOPs), ICH-GCP guidelines and regulatory requirements. Review and approve reports, ensure tracking, follow up and resolution of site issues have been completed in a timely manner. Ensure all project level study documentation is filed in the trial master file (TMF) in accordance with company SOPs and all archival procedures. Training team members, evaluating staff performance and leading the resolution of issues of the bioequivalence study.

Implement & audit the quality system Operate the quality management system to comply with ISO 9001:2008, GLP , WHO and maintain a state of control Audit for compliance to policies and procedures: on paper vs. practice Report on the performance of the quality system, including trends, that help decision making for targeted actions Responsible for supporting quality related customer complaints and Regulatory issues Promote continuous improvement of the Quality Management System through Lean Six Sigma methodologies. Lead effective team meetings and generate presentations, action items and outcomes. Generate reports and provide analysis on quality related metrics in order to recommend quality and/or process improvementsProcedures and specifications Ensure that procedures and specifications are appropriate and followed Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.) Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents Review and approve/reject reprocessing and rework proceduresBioequivalence Studies Verifying all the activities undertaken during the study Checking all the study data for reliability & tracability Verifying that the reports accurately & completely reflects the data of the studyReport to management  Report on product, process and system risks—and keep management informed Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed

(Analytical lab) Carryout the withdrawal and handling samples of the Raw Materials. Handling some of Bulk & Finished Product Samples Testing and analyzing samples according to the analytical methodologies& and pharmacopeias using a wide range of laboratory equipment (UV spectrophotometers, HPLC (Shimadzu, Agilent), Karl Fischer, Refractometer, Polarimeter ......... etc.) Record, report and interpret the analytical data. Ensuring that all the laboratory systems and equipment comply with GMP requirements, ISO 9001/2008.

(Analytical lab) Carryout the withdrawal and handling samples of the raw materials. Testing and analyzing samples according to the analytical methodologies& and pharmacopeias using a wide range of laboratory equipments ( UV spectrophotometers , Karl Fischer …….etc ) Record, report and interpret the analytical data Ensuring that all the laboratory systems and equipments comply with GMP requirements(Microbiological lab) Microbiological Analysis of Raw Materials, Primary Packaging Materials and Final Products according to the required Specifications & Pharmacopeias. Antibiotic Assay of Final Products. Microbiological Analysis of Water System. Assure the conformity of environmental conditions in different production areas. Preparation and Evaluation of Culture Media. Operation, Calibration and Validation of Microbiology Lab Equipment Follow-up the cleaning validation and equipments verification. Play a Role In The Collection of The Quality Control Data For The Annual Product Review. Involved in development of new product projects