Quality & Compliance Associate

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP)
  3. United Kingdom
Uxbridge, Middlesex
Posting date: 05 Feb 2019

ProClinical is advertising an exciting opportunity for Quality & Compliance Associate position, at a major biotechnology company with an extensive pipeline and commercial portfolio in oncology and immunology. The company is seeking for the Q&C Associate to join their team in Uxbridge on a contract basis.

Job Responsibilities:

  • Supporting the Affiliate Quality Management System (QMS).
  • Leading the administration of the change control process, commitment tracking and CAPA (corrective/preventative actions).
  • Supporting quality assurance projects and continuous improvement activities within the affiliate across all GxP areas.
  • Managing the affiliate compliance training system.
  • Supporting internal & supplier audits.
  • Administering affiliate Standard Operating Procedures (SOPs) and Work Practices (WPs) within the global document management system.
  • Working with Process Owners to support the creation of SOPs and WPs, including authoring, process mapping & formatting.
  • Conducting quality and compliance reviews of new procedures - providing feedback to Process Owners.
  • Supporting & administering the affiliate change control process, and tracking commitments and CAPA (corrective/preventative actions).
  • Advising on the development of training materials for new and updated procedures.
  • Participating in and/or leading at the appropriate for a within the affiliate Governance & Compliance Framework Audits & Inspection Readiness.
  • Participating in delivering the annual Quality Plan for the affiliates, including support of the annual audit programme.
  • Supporting with periodic Quality Review Audits of the affiliate and suppliers to ensure company compliance and highlighting risks.
  • Supporting in the preparation for and execution of corporate and Health Authority audits & inspections.
  • Generating reports of appropriate KPIs to demonstrate compliance levels within the Internal affiliate development.
  • Supporting the continuous education of the whole business on the importance of quality management & supporting the implementation of best practices.
  • Delivering intranet content & relevant communications to the organisation Compliance Training.
  • Ensuring the effectiveness of the affiliate quality training processes.
  • Managing the affiliate Compliance Training System (s), including the assignment of local training according to the affiliate training matrix.
  • Setting up new users within the training system and generating their curricula with line managers.
  • Developing & maintaining the Affiliate GxP training matrix, including a training analysis for new job roles.
  • Preparing and distributing monthly metrics and training completion reports as required.
  • Delivering compliance inductions for all new starters, including a relevant Code of Practice training for Field Force Records Management.
  • Leading records retention and ensuring good documentation practices in the affiliate.

Skills and Requirements:

  • At least a bachelor's in a life science/pharmacy degree.
  • Demonstrable experience within a Pharmaceutical company (ideally at an affiliate), including relevant regulatory experience.
  • Demonstrable experience in participating in audits and/or supporting quality reviews.
  • An established knowledge of good documentation and record retention principles.
  • Working knowledge of the quality management principles and applicable GxP areas, including ABPI and IPHA Code of Practice & Healthcare Compliance.
  • Excellent computer skills, with proficiency in Word, Excel, Outlook, and Visio Leadership.
  • An ability to multi-task whilst maintaining a very high level of accuracy and attention to detail.
  • A solution-oriented mindset, with an ability to lead projects and facilitate teams whilst being highly organised and efficient.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.