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.
- 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
If you would like to apply for this role, please send your CV and cover letter, detailing your salary requirements to firstname.lastname@example.org
- 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.
- 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.
- 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.
- 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.