Quality Systems Specialist

7 days ago


Cardiff, United Kingdom Reed Full time
Quality Systems Specialist
  • Job Type: Full-time
  • Location: Cardiff
  • Salary: Up to 38,000

We are looking for a Quality Systems Specialist to join our client's team in Cardiff. This role involves managing and enhancing quality systems processes. Ideal candidates should have at least 3 years of experience in a QA/QS environment, preferably in the medical device or pharmaceutical sector.

Responsibilities:

  • Implement and oversee policies and procedures to ensure compliance with regulatory bodies.
  • Provide guidance on established procedures and regulatory requirements.
  • Offer effective solutions to design and manufacturing teams for regulatory compliance.
  • Generate reports to track system performance.
  • Review and approve Quality Management System documentation for compliance.
  • Identify and enact changes to improve the Quality System efficiently.
  • Conduct training sessions on Quality System requirements.
  • Perform internal and inter-company audits.
  • Adhere to Company Quality Standards, GDP, and GMP.
  • Act as a backup for the Senior Quality Systems Engineer when needed.

Required Skills & Qualifications:

  • Science/Engineering/Quality-related qualification.
  • Minimum of 3 years' experience in a QA/QS environment in medical devices or pharmaceuticals.
  • Knowledge of relevant standards and regulations.
  • Proficiency in MS Word, Excel, and MRP systems.
  • Familiarity with GMP and audit processes.
  • Ability to work independently.
  • Excellent communication and interpersonal skills.
  • Strong record-keeping abilities.
  • Displays integrity, customer focus, accountability, and teamwork.

Benefits:

  • 25 days of annual leave plus bank holidays.
  • 10% annual bonus.
  • Non-contributory 10% pension scheme.

If you are interested in the Quality Systems Specialist role, click on the application link below.


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