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Quality System Manager

2 months ago

Oxford, United Kingdom Pharma Partners Recruitment Ltd Full time

Looking for a Quality Systems Manager to join an Oncology focused Biotechnology company based in Oxford.


Purpose:

Provide coordination and management in the operation of the Quality Management System (QMS).

  • Act as the main point of contact for the business in matters relating to the operation of the QMS.
  • To ensure compliance to regulatory requirements, internal polices, Standard Operating Procedures and standards in the operation of the QMS.
  • To help ensure continuous improvement of the QMS.


Experience:

At least 2 years’ experience in the operation of quality systems in a pharmaceutical quality related role. Experience of working within sterile pharmaceutical manufacturing and/or radiopharmaceutical manufacturing is desirable but not essential.


Duties:

  • Administration and management of the eQMS, document management and learning management systems.
  • Development and generation of metrics, measures and reports for the operation of the QMS.
  • Oversight and coordination, to ensure the quality and timely management of:
  • Change controls / Deviations / CAPAs / Product Quality Reviews / Complaints / Self-inspection
  • Quality Risk Register
  • Author and implement QMS procedures
  • Preparation and management of finished product labelling and patient information leaflets
  • Plan and conduct internal audits and self-inspections
  • Provide advice and encouragement to staff to ensure individual and company compliance
  • Provide training to staff on general or specific quality topics
  • Support the QA team in relation to quality investigations and initiatives
  • Prepare, manage and present materials for Quality Management Review
  • Contribute to continuous improvement activities and take ownership of continuous improvement tasks and projects.


Skills and Competencies:

  • Proactive approach and can-do attitude
  • Excellent written, verbal and presentation skills
  • Excellent organisational skills
  • Excellent IT skills for standard desk top packages (experience with Power BI desired but not essential)
  • Good analytical skills
  • Competent in problem solving, team building, planning and decision making
  • Sound knowledge of GMP and/or GCP


Qualifications:

A degree in a science related discipline.


Reporting to:

Associate Director, Quality Operations.


Flexible working available with the requirement to be onsite twice a week.