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Senior Quality Officer

  • Job reference: 919907
  • Location: Bedford, Bedfordshire
  • Salary: Up to GBP32000 per annum
  • Job type: Permanent
  • Sector: Manufacturing, Office & Commercial
  • Date posted: 30/05/2018

My global client has an exciting opportunity for a Senior Quality Officer. You will ensure the compliance of my client including regulatory legislation, ISO9001, ISO13485 is adhered to. You will carry out process reviews, risk assessments, qualification of storage areas, internal audits, training on QA and GDP processes.

Additionally, you will carry out non-conformance reporting, root cause analysis, corrective action & preventive action management, and data trending analysis and reporting.

You will act as deputy Responsible Person for my client, adhering to the Guidelines on Good Distribution Practice of Medicinal Products for Human Use.

The key responsibilities include;

  • Deputise for the named Responsible Person for my client, including but not limited to:
  • Review and release of returned products
  • Review of temperature data
  • Review and approval of major deviations
  • Management of recalls
  • Providing GDP storage declarations
  • Oversee change control projects
  • Review and approve company Quality Technical Agreements with clients and suppliers
  • Day-to-day technical management of the departmental resources
  • 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
  • Perform proactive data trend analysis to identify key areas for improvement, and propose / implement actions to address trends.
  • 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

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

  • Degree educated or equivalent in a science subject is desirable
  • Minimum of 3 years experience of 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.