Quality System Manager

7 days 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.


Ready to apply Before you do, make sure to read all the details pertaining to this job in the description below.

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.

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