Quality Assurance Officer

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 degree 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 GMP manufacturing environment

Desirable

  • Experience in a service company and with a very strong client orientation 

SKILLS

  • 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

This working hours for this role are on a 2-week shift pattern.

  • Week 1: 7am to 3pm,
  • Week 2: 12 noon to 8pm.

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.

Get In Touch.


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