Quality Systems Officer

PURPOSE & 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.

PERSON SPECIFICATION

QUALIFICATION

Essential

  • Educated to a HNC/HND level  

Desirable

  • Educated to a degree level in Life Sciences

KNOWLEDGE

Essential

  • IT skills – Microsoft packages

Desirable

  • Experience in Electronic Quality Management Systems

EXPERIENCE

Essential

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

Desirable

  • 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 

SKILLS

Essential

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

TO APPLY

If you would like to apply for this role, please send your CV and cover letter, detailing your salary requirements to lorraine.den-kaat@symbiosis-pharma.com

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

  • Provide QA coaching/guidance for cross functional groups to ensure compliance.
  • Coordinate and provide training across functional groups in Quality procedures, cGMP requirements, and QA concepts.
  • Provide support to management during third party audits.
  • 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.

Get In Touch.


By ticking the box and clicking “Submit” below, you consent to receiving thought leadership, industry news, and invitations by email or other electronic means, which Symbiosis Pharmaceutical Services believes may be of value to you, relevant to your work and tailored to your professional profile and interests. This may include promotional information on products, services and events provided or organised by Symbiosis Pharmaceutical Services. By clicking the "Submit” button, you confirm that the information you have provided above is correct, and you agree to Symbiosis' processing of your personal data, including its transfer internationally and to third parties, in accordance with it's privacy policy.