Quality Assurance and Compliance Officer

Quality Assurance and Compliance Officer

Bristol

Permanent

We are working with a Global Life Sciences company who have one of their locations in Bristol and are seeking a Good Manufacturing Practice (GMP) experienced Quality Assurance (QA) and Compliance Officer.

They are a leading developer and manufacturer of life science reagents, and have a growing QA department that you will be adding to. The location has had a huge amount of investment in the past few years especially creating a new GMP manufacturing facility.

The role holder will work on compliance activities related to Quality Management Systems and Good Manufacturing Practices.

What you’ll do:

• Ensuring compliance with Quality Management Systems, ISO 9001, and GMP regulations
• Assisting with Quality System audits at the Bristol location
• Maintenance of Non Conformances and Corrective Actions system. Working closely with colleagues to ensure all are effectively managed and closed
• Administration of QA documentation and Change Control processes
• Gathering and analysis of Quality Assurance data
• Assessment against KPI’s of data to ensure effectiveness of the quality management systems is monitored
• Creating Standard Operating Procedures (SOP’s)
• Regulatory audit participation
• Training of colleagues in QA and ensuring QA training material is kept up to date
• Regulatory compliance activities as needed

Your background:

• BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
• A high level of experience working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
• Experience of working within a cGMP environment.Experience of working to EudraLex Volume 4, Part II or to 21CFR part 820.
• Experience of working to ISO 9001 or ISO 13485.
• Experienced internal auditor for ISO 9001/ISO 13485 and cGMP.
• Experienced in investigation of customer complaints and customer technical support.
• Experience with Customer and Regulatory audits.
• Experienced in the critical review of CAPA / non-conformances / deviations.
• Experience of data analysis against KPIs and reporting trends to Top Management.
• Experienced in documentation management systems and change control processes from a Quality Assurance perspective.
• Experience of Supplier Quality processes.

We are seeking in the person excellent team-working skills and a methodical, process-oriented approach to work.

Organised with a keen attention to detail, ensuring tasks are completed efficiently and accurately. Time management skills to meet deadlines while maintaining quality.

Strong verbal and written communication and effectiveness in conveying ideas and collaborating with others. Additionally, a strong problem-solving ability, flexible when approaching challenges with a positive, can-do attitude.

On this occasion LiCa Scientific is acting as an employment agency.