Quality Assurance Specialist
We are working with a multinational Pharmaceutical company that have a vacancy for a Quality Assurance (QA) Specialist. They are seeking someone with several years experience in a QA role, who will bring knowledge of GMP, GCLP, GDP and GCP. MHRA and FDA requirements, electronic systems knowledge and excellent quality systems knowledge. This is a permanent role with a competitive salary and package on offer.
What you’ll do:
You will be responsible for the effective administration, monitoring and completion of Quality System activities. This will involve constantly driving excellence and efficiency throughout the organisation in QA. You will be using your technical and regulatory knowledge to solve problems and assist team members in QA issues.
- Conduct audit checks in line with internal programme
- Coordinate and complete external vendor audits
- Manage and administer customer complaints
- Track corrective and preventative actions (CAPA’s), from internal and external audits
- Where possible, close CAPA’s and provide help and advice to others looking to close theirs
- Maintain and update the Approved Supplier list
- Complete assessment of suppliers
- Complete risk assessments
- Report Key Performance Indicators
- Conduct GxP training
- Review Quality documentation, collation of timely Quality Management Reviews
- Use Quality Risk assessments to ensure that risks are being adequately controlled
- Ensure investigations of deviations, errors, failures and adverse events needing documented review and action
- Review non-conformance, information raised by audit, deviations, complaints and use professional judgement to make quality decisions and promote quality improvements.
You will have a scientific degree with experience of working in QA. We require a good knowledge of GMP, GLP, GCLP, GDP and GCP regulations. You will have knowledge of MHRA and FDA requirements and ISO requirements.
We are interested in hearing from candidates with experience of supplier audits, process delivery improvements, vendor management and risk management experience.
On this occasion, LiCa Scientific is acting as an employment agency.