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Careers in Clinical Quality Assurance

Quality Assurance (QA) is a key function in the pharmaceutical and the clinical research industry. Quality Assurance department is responsible for maintaining the overall quality systems of the whole organization to ensure that the organization follows standard operating procedures, guidelines and regulations. Quality Assurance professionals in clinical research are employed in pharmaceutical companies or by contract research organizations.

Quality Assurance includes different levels of career growth i.e. Quality Assurance Executive, Quality Assurance Officer or Manager, Quality Assurance Auditor and various responsibilities are assigned according to these levels.
Following are some main responsibilities of Clinical Quality Assurance Professionals:

  • Timely evaluation and coordination of annual reviews of SOPs, updating and making them effective
  • Equal participation and coordination in writing new SOPs as required in due course of time
  • Tracking and archival of SOPs, their distribution, monitoring and control
  • Performing Quality Control review of documents, case report forms, protocols, informed consents, policies, procedures and reports of undertaken clinical studies
  • Evaluating and taking corrective actions on deficit areas on the basis of feedback
  • Performing Internal Audit on site-specific files, master files and various others as per the local and international guidelines and regulatory requirements
  • Participating, developing and implementing a comprehensive and standardized Quality Management Plan for the organization
  • Collecting, updating and communicating various local and international regulations and guidelines, important information among various departments
  • Providing training on quality and improving skills of individuals involved in clinical operations and data management
  • Conducting clinical trial audits to determine whether evaluated activities are conducted appropriately and the data generated are accurately reported according to Good Clinical Practice, Protocol and SOPs

  • Education:

    - Master's or Bachelor's degree preferably in Life Sciences or Pharmacy
    - Excellent knowledge of ICH GCP and regulatory guidelines

    Skills:

    - Strong understanding of ICH-GCP and clinical research process
    - Ability to assess and identify GXP and quality related issues
    - Goal oriented and meticulous
    - Demonstrate management skills and ability to meet timelines
    - Dedicated with strong sense of responsibility
    - Independent and should have an eye for detail
    - Should be abreast with industry trends and compliance
    - Excellent verbal and written communication skills

    Which Course/Program should I choose if I want to become a Clinical Quality Assurance Professional?

    Program recommended if you wish to become a Quality Assurance Professional in Clinical Research is:


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