Senior Clinical Quality Associate

4 days ago


St Albans, United Kingdom Pharma Partners Recruitment Ltd Full time

Senior Clinical Quality Assurance Associate


Apply (by clicking the relevant button) after checking through all the related job information below.

Remote - some requirements to go into Head Office in Hertfordshire 1-2 times a month.

The Senior Clinical Quality Assurance Associate will be working with a CRO with a market leading reputation. You will be reporting to the Director of Clinical QA.

Responsibilities:

  • Develop and maintain ICH-GCP compliant processes and procedures.
  • Support with performing Internal Quality Audits, CAPA and Quality Management Reviews.
  • Support the Director of Clinical QA with organisation and hosting of regulatory inspections and Sponsor/Client audits.
  • Communicate any critical compliance risks noted from these activities to Director of Clinical QA.
  • Support with performing external vendor audits and work with vendors and service delivery personnel in eliminating problems via root cause analysis techniques.
  • Support and maintain the eQMS.
  • Contribute to updates to and maintain CQA Standard Operating Procedures (SOPs) that support the Quality Systems.
  • Prepare and support in preparing annual reports and quality trending reports.
  • Utilise guidance documents, international standards, or consensus standards and interpret for guidance.

Requirements:

  • Minimum degree (BSc) in Life Science or related discipline.
  • 3 years + of demonstrated CQA experience in regulated industry such as pharma, biotech, CRO.
  • Full understanding of ICH/FDA GCP guidelines, with a working knowledge of GCP.
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
  • Understand device regulations, development processes and FDA / EMA inspection procedures is also required.
  • Experience/Involvement in FDA / EMA/UK inspections.
  • Experience developing SOPs, reviewing internal clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs.

If this role sounds of interest to you, please reach out for a confidential discussion by applying to this job ad.


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