Responsibilities: 1.Manage staff in accordance with organization's policies and applicable regulations, including without limitation: planning, assigning, and directing work; managing performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; acting as a coach and mentor for subordinates as they develop in their role. 2.Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. 3.Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. 4.Monitor updates for regulatory legislations and/or guidelines. 5.Conduct review of documents, procedures, facilities… etc., to ensure compliance to the regulatory requirements. 6.Perform review and quality assurance for reports and documents to be submitted to the regulatory departments. 7.Review the responses of the audit or inspection findings for appropriateness and completeness. 8.By following approved procedure and schedules, conducting audits either independently or collaboratively with other QA uditors. 9.Ensure timely completion of routine QA procedures. 10.Work collaboratively with each department head in the assessment of vendors' qualifications. 11.Assisting in project related or non-project related audits/inspections conducted by customer or regulatory authorities. 12.Write and issue audit reports or any non-conformances form in accordance with SOPs. 13.Ensure that audit findings are clearly made to the relevant project team members, department heads and upper management. 14.Participate in the investigation of non-compliance, problem reporting, or complaint issues. Follow through to verify corrective/preventive actions are appropriate and enforced as well as tracking and monitoring performances of the actions taken before case closed. 15.Perform housekeeping on documents generated as a result of QA activities. Provide inputs to the development of departmental quality system process. 16.Manage SOPs according to company policy or regulatory agencies. 17.Conduct provisional tasks assigned by line manager. 18.Establish training plan for junior QA specialist and provide training to ensure compliance with company policy and regulatory requirements. 19.Perform the tasks assigned by line manager.

The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: Perform analysis work according to SOPs and guidance. Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods. Manage lab logistics, including purchasing, inventory control, and payment processing. Maintain instruments and ensure cleanliness and maintenance of the workspace. Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting. Attend training courses related to CAP/GCP/GLP/regulatory requirements. Study Based Responsibility (if needed) Analytical Study Director in Study Work as the Study Director, responsible for the overall conduct and final report of the study. Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies. Make study plans, amendments, and SOPs available to study personnel. Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary. Document and record all generated raw data. Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion. Study Personnel in Study Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice. Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations. Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.