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Interim Quality Assurance Specialist

Interim Quality Assurance Specialist

  • Location

    Warwickshire, England

  • Sector:

    Supply Chain

  • Job type:

    Contract

  • Salary:

    £120 - £170 per day

  • Contact:

    Adam Dennison

  • Contact email:

    adam.dennison@1st-executive.com

  • Job ref:

    J12086_1543479291

  • Published:

    18 days ago

  • Duration:

    12 months

  • Expiry date:

    2018-12-29

  • Startdate:

    ASAP

  • Interim Quality Assurance Specialist - £120-170p/d
  • Warwickshire

An Interim Quality Assurance Specialist at £120-170p/d is required for a unique specialist manufacturing organisation who are the world leaders in their field, and a rapidly expanding FTSE100 organisation. A 12 month initial contract in Warwickshire, likely to extend, and providing long term stability, this is an exciting opportunity within Quality Assurance and Regulatory Affairs for a candidate who is looking to develop their experience within a global, diverse and fast-paced function, and a world leading brand.

Role:

This Quality Assurance position is responsible for representing the function for all Field Safety Corrective Actions.

  • Complete and/or manage Competent Authority reporting activities
  • Act as single point of contact with the UK & Ireland Competent Authorities
  • Collate and report evidence of FSCA closure for each affected country within EUCAN region.
  • Direct non-standard questions to the relevant functions/teams
  • Manage Competent Authority expectations and ensure timeliness of responses
  • Develop and assist in product registrations & re-registrations, including the supply of necessary documents for Europe and Canada and to existing approved countries for our products.
  • Managing and obtaining legalization of documents for our customers.
  • Assist in the development, review and implementing regional policies and procedures based on corporate requirements.
  • Assist in regulatory aspects of commercial business relationships to ensure compliance
  • Assess commercial activities in the EU for compliance and propose and implement potential solutions.

Required Skills:

  • Minimum 1-2 years experiences in regulatory affairs or quality assurance
  • Minimum 3 years Quality Assurance activities related to medical devices or pharmaceuticals
  • Proficient in Word and Excel, and good writing skill is needed. Experience in MS Access, MS Visio, Agile, and SAP desirable.