Quality Systems Officer

purpose and scope of the position

The Quality Systems Officer contributes to developing Symbiosis’ mutually beneficial relationships by assisting in maintaining a comprehensive quality management system to maintain inspection readiness and ensuring adherence to all developed quality systems and promoting continual development of quality systems where necessary.


Stirling, Scotland

person specification



  • Educated to a HNC/HND level


  • Educated to a degree level in Life Sciences



  • IT skills – Microsoft packages


  • Experience in Electronic Quality Management Systems



  • Experience in a regulated manufacturing environment
  • Experience in data review/analytics


  • Experience in a GMP manufacturing environment
  • Direct experience in GMP supplier quality and change control
  • Experience in a service company and with a very strong client orientation



  • Effective communication skills
  • Flexible and adaptive team player
  • Ability to perform multiple tasks effectively in a busy environment
  • Effective planning and organisational skills

key accountabilities

Quality Systems

  • Develop, monitor, improve, and maintain procedures to ensure compliance with pharmaceutical quality systems.
  • Help facilitate key quality sub-systems.
  • Investigate and report quality issues, escalating to management as required.
  • Support, develop, implement, and monitor continuous improvement activities.
  • Responsible for driving and producing quality system trending reports.
  • Deal with QMS management and closure – NCRs, CAPA, Change Control.
  • Participate in internal, external, supplier, 3rd party audits and regulatory inspections.
  • Support supplier management processes.
  • Support the management of the Quality Review Board and Annual Product Quality Review.
  • Participate in key business projects by supporting the Quality Manager to ensure appropriate quality systems oversight.

Regulatory Co-ordination

  • Support the compliance of regulatory administration
  • Support and advise on the implications to the Symbiosis license as a result of key changes.
  • Support the compilation and coordination of responses for client regulatory submissions

Business Support

  • I provide QA coaching/guidance for cross functional groups to ensure compliance.
  • I coordinate and provide training across functional groups in Quality procedures, cGMP requirements, and QA concepts.
  • I provide support to management during third party audits.
  • I train staff in QA related procedures and concepts as directed by the Head of Quality Systems.

Managing Relationships

  • Attend, participate and contribute to regular staff meetings, as necessary.
  • Invest in developing relationships with all staff
  • Invest in developing relationships with the management team to ensure we are a high performing team and Symbiosis’ services meet expectations.
  • Act as an ambassador for the company.

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