Quality Assurance Officer

PURPOSE & SCOPE OF THE POSITION

Symbiosis Pharmaceutical Services was established in 2011 in response to increasing global demand for niche, sterile manufacturing specialists that could satisfy product supply needs for clinical trials.

We are a UK-based contract manufacturing organisation (CMO) that specialises in the GMP manufacture and sterile fill-finish of vials for clinical trials and low volume commercial supply.

Our biologic and small molecule production capabilities support biotech and pharmaceutical companies across the world that require injectable products.

We are looking to appoint a Quality Assurance Officer in Stirling to develop 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

QUALIFICATIONS

  • Educated to a degree level (essential)
  • Educated to a degree level in Life Sciences (desirable)

KNOWLEDGE

  • IT skills – Microsoft packages (essential)
  • Experience in Electronic Quality Management Systems (desirable)

EXPERIENCE

  • Experience in a GMP manufacturing environment  (essential)
  • Experience in a service company and with a very strong client orientation  (desirable)

SKILLS

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

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 COORDINATION

  • 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

The working hours for this role are on a 2-week shift pattern: Week 1 – 7am to 3pm, Week 2 – 12noon to 8pm

TO APPLY

If you are interested in applying for the role of Quality Assurance Officer at Symbiosis please send your CV and covering letter to Lorraine Den-Kaat by email to: Lorraine.Den-Kaat@symbiosis-pharma.com

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