Compliance Associate (GCP/QA/Quality)

  • Location

    Milton Keynes, Buckinghamshire

  • Sector:

    Healthcare

  • Job type:

    Permanent

  • Salary:

    £40000 - £45000 per annum

  • Contact:

    Experis UK

  • Contact email:

    Paul.White@experis.co.uk

  • Job ref:

    PW/389_1594285704

  • Published:

    about 1 month ago

  • Expiry date:

    2020-08-10

  • Client:

    #

Compliance Associate

Permanent Opportunity

Milton Keynes (with flexible working hours/remote working)

Salary: Up to £45k base + bens

ASAP Start

OVERVIEW:

The role will contribute to the strategic design, implementation and delivery of quality management and quality assurance to the global and local operational teams as part of the Quality Management department. You will ensure all functions, programs and projects for the company (and all partners) at all locations are working in compliance with company quality standards and written procedures, Health Authority (HA) guidelines and regulations, and local laws. This includes all clinical trials, pharmacovigilance, data management and information technology. Ensure full, compliant documentation is present in collaboration with company functions: Nursing, Pharmacy, Vendor Services, Project Management, Regulatory, Training, HR, IT, Corporate Services and other relevant support functions.

KEY ACCOUNTABILITIES:

Audit and Systems Review

  • Perform regular study reviews (as per the approved schedule) by assessing project files and archives to ensure completeness and compliance with regulations such as GCP, GMP and GDP along with medical and nursing requirements.
  • Host and be the point of contact for customer & vendor audits and regulatory inspections.
  • Supports stakeholders in preparing for related Health Authority inspections. Assists in Back-room Inspection activities and support including assistance in preparation and responses to Health Authority inspections and customer audits.

Training and Knowledge Management

  • Assists in the development and implementation of effective training programs that support company quality objectives, and in the capture and dissemination of lessons learned.

Governance and Oversight

  • Monitoring and communication of audit and inspection findings.
  • Collate trend analyses, quality metrics and key performance indicators from the business and report to the Operating Board each month. Report quality trends to division heads on a regular basis.
  • Provide advice and support to the operational teams and functional heads as required.
  • Ensure project learnings, audit findings and issues are integrated into company Quality Management System (QMS).
  • Coordinate and follow-up on audit responses, CAPAs (project, vendor & audit), SOP deviations and maintain log of findings.
  • Attend Board sub-group meetings to provide Quality Management updates to functional heads and the Quality Director.

Continuous /Process Recommendations

  • Regular liaison with Director of Continuous Improvement, Training Manager and senior operational managers, the Quality Board sub-group, CEO-Quality meetings and the functional group-quality group meetings.
  • Regular liaison with functional heads and Quality Organisation.
  • Ensure follow up training is arranged based on audit and review findings.
  • Provide input into company change management and continuous improvement systems.

SKILLS/EXPERIENCE REQUIRED:

  • A Bachelor of Science BSc (Hons) 2.2 or above (or equivalent) degree is required.
  • Working knowledge of established project management tools.

  • At least 2 years experience in operational activities within the pharmaceutical Industry.
  • Experience in a clinical research environment with strong working knowledge of ICH-GCP E6 regulations.
  • Working knowledge of the drug development process, quality assurance procedures and policies, and quality evaluation techniques.
  • Knowledge of the clinical trials regulations, auditing and inspection process.
  • Proficient in Microsoft Office applications.
  • Confident communication skills both written and verbal, including report writing.
  • Pays attention to detail. Process focused. Able to forensically examine documentation for errors and uncover non-compliance.
  • Able to work independently and as an effective member of a multidisciplinary team.
  • Able to prioritise and schedule workload effectively.
  • Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks.
  • Excellent English both verbal and written.

Desirable

  • Postgraduate qualification in a quality discipline.
  • Certified in an established project management methodology.
  • Understanding of commercial or trial related nursing services.
  • Knowledge of worldwide GxP compliance regulations
  • Sound research and development practices, scientific and quality terminology.
  • Able to present information with confidence and enthusiasm.

Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Expeirs within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.