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QA Officer

Job LocationRuncorn
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced QA Officer to be responsible for helping to maintain and improve the Quality Management System as part of the Quality team by identifying potential improvements and efficiencies andhelping to develop, revise and implement Quality procedures and policies.The QA Officer will work with the Quality team and wider design development team through the design, development and launch of products, which will include compliance with the requirements of ISO 13485.Duties may include:

  • Compile and maintain Medical Device Files, Technical Files and Device Master Records in preparation for Regulatory submissions in various markets globally with guidance from the Regulatory Manager.
  • Take an active role in the product risk management process.
  • Take an active role in software development compliance review and approval.
  • Support design review and control of change processes during product development.
  • Maintain an up-to-date awareness of relevant regulations which may impact the QMS and communicate this effectively.
  • Help to implement systems that facilitate productivity, improve processes and guarantee efficacy.
  • Be involved in and lead training sessions to ensure the understanding and compliance of all employees.
  • Administer, prepare, conduct and report internal quality system audits and external vendor assurance audits as necessary.
  • Work within the QA team to maintain the companys electronic Quality Management System, including monitoring and progression of CAPA and audit actions.
  • Promote the benefits of the quality system to all employees.
Skills and experience:
  • Experience of working with ISO 13485 is essential as is a good understanding of risk management for medical devices under ISO 14971.
  • A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work and motivate with utmost tact and diplomacy.
  • A degree in Life Sciences.
  • Outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
INDHP

Keyskills :
DMRGMPManufacturingPharmaceuticalProductionISO13485

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