MMS Hiring for Clinical Quality Assurance Associate Role

MMS Hiring for Clinical Quality Assurance Associate Role

5 April, 2022

Responsibilities:

  • Support efforts to establish, maintain, and continually improve the Integrated Management System (IMS) (i.e., Information Security Management System and Quality Management System) ensuring compliance to ISO standards and regulatory requirements.
  • Ensure organizational compliance to legal & regulatory requirements (e.g. ICH, 21 CFR Part 11, GxP, GDPR, etc.) and promote understanding, interpretation, and application of requirements. 
  • Supports preparation for audits (sponsor, regulatory, certifying body).
  • Facilitates drafting of audit responses
  • Track quality metrics and KPIs
  • Supports meeting preparation (Management Review, capabilities calls, etc.)
  • Continually monitor and review quality records and documents within the eQMS
  • Support external audits including remote audits and requests for information (RFI) ensuring accuracy of responses pertaining to the IMS.
  • Support IMS document updates and ensure accuracy and adequacy of IMS documents.
  • Support Training function and development and delivery of training.
  • Promote quality, customer satisfaction, and improvement focus among the organization and perform quality improvement and analysis tasks as assigned.

Requirements:

  • College graduate in scientific, medical, business, or related field, or equivalent experience
  • 2-4¬†years’ experience in GxP industry
  • Familiarity with current ISO 9001 and ISO 27001 standards
  • Familiarity with 21 CFR Part 11, FDA, ICH, Privacy & Information Security requirements and standards, and GCP, cGxP requirements
  • Experience with electronic Quality Management Systems (eQMS)
  • Proficient in MS Office applications
  • Excellent communication skills, ability to multitask, attention to detail, and organizational skills

Apply through this link

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