PURPOSE & SCOPE OF THE POSITION
The Quality Assurance 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
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
The working hours for this role are on a 2-week shift pattern
- Week 1 – 7am to 3pm
- Week 2 – 12noon to 8pm.
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.
