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Quality Assurance Manager

2 months ago

Oxford, Oxfordshire, United Kingdom Pharma Partners Recruitment Ltd Full time
About the Role

We are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Quality Assurance Manager, you will play a critical role in ensuring the quality and compliance of our operations.

Key Responsibilities
  • Quality Management System (QMS) Coordination
    • Act as the primary point of contact for the business in matters relating to the QMS.
    • Ensure compliance to regulatory requirements, internal policies, Standard Operating Procedures, and standards in the operation of the QMS.
    • Contribute to the continuous improvement of the QMS.
  • Quality Assurance and Compliance
    • Administer and manage the eQMS, document management, and learning management systems.
    • Develop and generate 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.
    • Prepare and manage finished product labeling 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 organizational skills.
    • Excellent IT skills for standard desktop 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.
    Requirements
    • A degree in a science-related discipline.
    • 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.
    Reporting and Working Arrangements

Reporting to: Associate Director, Quality Operations.

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