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Senior CQV Specialist

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360 Resourcing Solutions

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Location:
United Kingdom , Keele

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world. The Senior CQV Specialist (Commissioning, Qualification, and Validation) will primarily be accountable for the qualification and validation for processes, facilities, equipment, and computer system validations in a medical device (cGMP) environment.

Job Responsibility:

  • Organise and lead validation activities to provide an effective validation service
  • Ensure all required documentation for a validation exercise, including validation protocols and summary reports, are created and maintained
  • Provide input and technical expertise for the creation and revision of relevant Standard Operating Procedures (SOPs) and other quality/validation documentation
  • Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives and schedules
  • Ensure design projects relating to processes, facilities, equipment, and computer system validation are in compliance with regulatory and company requirements
  • Provide validation support and advice to operations and other areas of the business as required to ensure that all operations are carried out in compliance with regulatory and company requirements
  • Provide specialist knowledge on validation of
  • process, facility, equipment and application of computer systems used within production and service
  • Support a continuous improvement culture within the business
  • Ensure staff have required knowledge and training when performing validation activities on department, site, processes, and procedures
  • Develop work plans, assign tasks, and supervise teams to achieve the overall site validation requirements

Requirements:

  • Level 6 within a science regulated industry or relevant experience
  • Minimum 8 years validation experience within pharmaceutical/medical devices, including cleaning, analytical methods, lab equipment, and computer system validation and re-qualification
  • Creation of validation documentation from URS to VSR, SVMP (subject to QA input)
  • Knowledge of Quality Management Systems
  • Comprehensive knowledge and experience with the following industry regulations and guidance: FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices), ISO 13485:2016 (Medical Devices - Quality Management Systems), ALCOA+ principles for data integrity (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ICH Q9 (Quality Risk Management) and its application to validation/qualification
  • Excellent communication skills
  • Ability to meet deadlines
  • Attention to detail
  • Demonstrate a positive and enthusiastic attitude

Nice to have:

  • Manufacturing process validation experience preferable, including validation of new processes and changes to existing processes
  • Processes using the lifecycle approach to validation
  • Proficient in Kneat, CAPA, Change Control or other alternative system and software packages
  • People management skills
  • Occasional overtime requirements
  • Full, clean driving licence
What we offer:
  • Company events
  • Company pension
  • Employee discount
  • Free or subsidised travel
  • Free on-site parking

Additional Information:

Job Posted:
March 02, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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