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Senior Quality Officer

  • Job reference: 928178
  • Location: Bedford, Bedfordshire
  • Salary: GBP28000 - GBP32000 per annum
  • Job type: Permanent
  • Sector: Stock & Inventory Controllers, Transport and Logistics
  • Date posted: 14/10/2019

Our global 3PL client is currently looking to add a Senior Quality Officer to their team in Bedford. The main focus of this role will be to provide a GDP focused knowledge to the organisation, ensure compliance to relevant regulatory legislation whilst carrying out process reviews, risk assessments, internal audits and training on QA and GDP processes.

Key Responsibilities

  • Deputise for the named Responsible Person, including but not limited to:
    • Review and release of returned products
    • Review of temperature data
    • Review and approval of major deviations
    • Management of recalls
    • Lead Recall Committee meetings as & when required
    • Providing GDP storage declarations to all areas
    • Oversee change control projects & adaptations to changing guidelines
    • Review and approve company Quality Technical Agreements with clients and suppliers

  • Promote Quality to the wider business
  • Plan, perform and follow-up on self-inspections and supplier audits allocated for completion
  • Hosting of client/3rd party audits, and managing any non-conformances to satisfactory outcome
  • Hosting client quality review meetings
  • Develop and deliver Teammate training in quality aspects and GDP requirements
  • Perform detailed root cause analysis on both internal and external non-conformances to ensure corrective measures can be implemented
  • Analyse the deviation database to determine opportunities for improvement
  • Carry out process reviews across the business to ensure most effective and compliant processes are adopted
  • Review and approve quality documentation: SOP's, Work Instructions, and Forms, to ensure compliance with required standards and consistent structure and language are used
  • Perform and facilitate risk assessments on GDP and quality processes
  • Review and approve temperature qualification reports for all storage and transportation areas
  • Assist with any Quality related issues and reasonable management requests
  • Building relationships with internal Stakeholders

Skills & Experience Required

  • Degree educated or equivalent in a science subject is desirable
  • Previous experience working within a Quality department certified to ISO9001 or ISO13485 standard
  • Experience within Pharmaceutical and/or Healthcare Industry desirable
  • Trained and qualified Lead Auditor (BSI or IRCA registration desirable)
  • Ability to present and communicate with clarity and confidence to a wide range of audiences
  • Computer literate in Microsoft applications
  • Able to work under pressure and meet strict deadlines
  • Able to prioritise and complete work with minimal supervision
  • Able to work within a dynamic team and complete individual tasks
  • Enthusiastically drive vision and change within the business
  • Ability to influence at all levels
  • Role requires some off-site travel and overnight stays

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.