Quality System Coordinator

£0.00 - £45000.00 per annum
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
Slough, Berkshire
Posting date: 08 Mar 2019

ProClinical is advertising a vacancy for a Quality System Coordinator, External Manufacturing position with a specialty-driven biopharmaceutical group at their office in Berkshire. The company, which focuses on innovation and Specialty Care, develops and commercialises innovative medicines in three key therapeutic areas - Oncology, Neuroscience, and Rare Diseases. Exemplifying this is their growing portfolio, which includes therapies for prostate cancer, neuroendocrine tumours, renal call carcinoma, and pancreatic cancer. This is an exciting opportunity for an applicant to develop their career an innovative and transformative player in the neuroscience field.

The Quality System Coordinator is responsible for the provision of QA support to the EMO team for all Drug Substance and Drug Product manufacturing and testing activities performed at Contract Manufacturing Organisation (CMOs) and Contract Testing Laboratories (CTLs). They will provide direct support to the Director of Quality in the management of the day to day aspects of the QA department, including deviation close out and associated investigations, supporting the Product Quality Review and Change Control processes and participating in quality-based projects. They will assume responsibility for the providing QA Support and maintenance of various Quality systems, metrics, and documentation. The Quality System Coordinator will also provide support on product manufacturing and testing to third parties and to the Technical, Regulatory CMC functions within the company's External Manufacturing Organisation.

Job Responsibilities:

  • Carrying out the follow-up of the action plans associated with the audits of suppliers and subcontractors.
  • Updating the quality indicators (KPI) to monitor the quality performance of the various subcontractors and suppliers.
  • Maintaining up-to-date lists of approved suppliers and subcontractors.
  • Maintaining oversight/delivery of the Quality Management System.
  • Proposing an update of the risk index associated with the various subcontracts and suppliers to update the vendor risk mapping.
  • Conducting a generation and analysis of the period quality reviews (APR) sent by suppliers and subcontractors in accordance with the procedures in place.
  • Completing the control charts and indicators associated with monitoring the quality of outsourced products.
  • Producing PQR summary documents for review by the QA Manager.
  • Implementing all the activates related to the handling of complaints & deviations in accordance with the applicable company procedures, including:
    • Receipt and Analysis from subsidiaries.
    • Coordinating investigations with subcontractors and approving their conclusion.
    • Approving the proposed action plans to address the root causes.
    • Monitoring the effectiveness of proposed actions.

Skills and Requirements:

  • At least a BSc or equivalent in a Life Sciences discipline, chemistry, or biochemical engineering. An MSc is ideal.
  • Five to seven years of hands-on experience gained in both Quality Assurance and Quality Control departments, ideally with at least three years in a Supervisory position.
  • Thorough knowledge of cGMP guidelines gained through practice experience of supporting cGMP manufacturing operations.
  • Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments, and preparing for FDA and EMA inspections.
  • Knowledge of biotech and aseptic manufacturing and processes, along with product testing methods.
  • Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or equivalent Quality systems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

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 contact Josh Godden at +44 2038540101 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.