PURPOSE & SCOPE OF THE POSITION
The Quality Assurance Officers contribute 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.
location
Stirling, Scotland
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
Desirable
- Experience in a GMP manufacturing environment
- 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
Operational Quality Assurance
- Develop, monitor, improve, and maintain procedures to ensure compliance with EU/FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals.
- Perform batch release duties in accordance with relevant procedures.
- Investigate and report quality issues, escalating to management as required.
- Develop, implement, and monitor continuous improvement activities.
- Responsible for BMR reviewing and issuing.
- Deal with QMS management and closure – NCRs, CAPA, Change Control.
- Trend and report batch reviews and QMS data.
- Quality oversight of shipment activities.
- Participate in internal, external, supplier and 3rd party audits and inspections.
- Support supplier management processes
Regulatory Co-ordination
- Review and issue new and/or revised SOPs.
- Deal with post manufacture document review (BMRs).
- Responsible for raw material release including review and issue of new RMS.
- Responsible for label approval.
- Responsible for room release.
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 Quality Assurance Manager and Quality Director.
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.
