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QA Activities
·Plan, schedule and perform internal, client and vendor audits and reviews as required in order to assure that clinical studies managed by R&G PharmaStudies are of the highest standard and in compliance with the requirements of R&G PharmaStudies or Sponsor SOPs, study protocols and GCP.
·Evaluate significance of audits findings and coordinate the findings responses with functional departments and/or study teams.
·Manage processes for internal non-compliance corrective action plans.
·Be responsible for the development of Quality Management System from the GCP perspective, which includes writing, reviewing, updating and promoting SOPs and any other associated documentation and deploying quality related systems.
·Review and recommend new or changes to existing SOPs and systems to reflect current company and industry practice.
·Develop audit checklists, plans and agendas of audits for QA internal and external audits.
·Assist in or host client audits and/or health authority inspections.
Training Activities
·Provide training to internal staff and/or investigational site staff on regulatory requirements, compliance standards, and quality initiatives in preparation of regulatory inspection.
·Provide GCP compliance training, audit and inspection readiness training.
Advisory and Supporting
·Advise on and prioritize the training needs of Clinical Operation staff in liaison with Training staff and the Clinical Operation team.
·Liaise with Clinical Operations, MA, RA, DM, SA, SMO and Pharmacovigilance to assist in interpretation and application of GCP requirements.
·Provide on-going support to clinical project managers on compliance and quality issues.
MINIMUM REQUIREMENTS
Skills
·Demonstrated effectively balance quality and speed in complex situations.
·Demonstrated ability to work in a team environment.
·Demonstrated ability to work under pressure and requires minimal supervision.
·Strong interpersonal and communication skills.
·Strong analytical skills.
·Excellent planning and organizational skills.
·Excellent oral, written and presentation skills.
Education
·Bachelor degree or above in Clinical Medicine/Pharmacy/Biological Sciences or equivalent.
Language Skills
·Competent in written and oral English.
Work Experience
·Minimum of 3-year experience in pharmaceutical/medical device industry and preferred having experience in clinical operations and project management. Minimum 1 year working experience in compliance/quality control/quality assurance.
·Working experience in developing or rolling out training programs.
·Thorough knowledge of drug development process.
·Detailed knowledge of ICH-GCP Guidelines and regulations.