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Quality Manager

  • Job reference: 932092
  • Location: Bedfordshire
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 24/09/2020

My global client has an exciting opportunity for a Quality Manager to be responsible for the management and operational performance of the Quality Department and Quality related activities. Reporting into the Head of Quality and based in Bedford, with the ability to work from home 1-2 days per week.

You will ensure compliance to the companies Quality Management System and regulatory requirements set out by the MHRA. You will act as the named responsible person for my clients MHRA licenses.

Key Responsibilities include;

  • Ensuring that the companies Quality Management System is operating consistently and effectively.
  • Ensure compliance to procedures ISO 9001, ISO 13485 as well as GxP legislation and regulatory expectations and requirements.
  • Defining standards for quality activities across the business, measuring and reporting to Senior Management
  • Ensure quality oversight and input into the Employee Training Program
  • Provide company training on QA topics.
  • Ensure a robust supplier management process is in place and adhered to
  • Incorporate Quality Risk Management and Risk Assessment into all relevant processes.
  • Handle complaints and deviations, including root cause analysis and corrective action
  • Ensure traceability and follow up of recalls
  • Ensure qualification/validation of systems/processes/facility
  • Manage the Quality department including team leadership duties such as 121's, target figures, allocation of workloads and staff development etc
  • Ensure there is self inspection programme in place which is adhered to
  • Maintaining an awareness of new proposed legislation that impacts the business and by communicating any changes to the Senior Management Team.
  • Preparing, reviewing and approving Technical/Quality Agreements
  • Release of product returned from customers in accordance with MHRA and GDP guidelines
  • Host MHRA and external audits as required
  • Respond to external audits with recommendations from findings
  • Attend client meetings, representing the Quality Department

Qualifications/Experience/Knowledge/ skills required for the job;

  • Extensive experience of working in Quality/ Regulatory Environment
  • Implementation and/ or maintenance of an ISO9001 quality system
  • Root Cause Analysis techniques
  • Sufficient experience working in a management role
  • Eligible to act as a responsible person
  • Extensive knowledge of Good Distribution practice legislation
  • Sufficient experience within the pharmaceutical industry
  • Knowledge of Pharmaceutical product storage conditions
  • Experience of environmental monitoring and qualification
  • Lead Auditor qualification and IRCA registration is desirable
  • Excellent presentation/communication skills at all levels
  • PC literate and advanced user of Microsoft applications

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.