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Quality Manager (Medical Device / Pharmaceutical Manufacturing)

Quality Manager (Medical Device / Pharmaceutical Manufacturing)

  • Location

    Warrington

  • Sector:

    Pharmaceutical & Chemical, Scientific

  • Job type:

    Permanent

  • Salary:

    £48000 - £52000 per annum, Benefits: benefits

  • Contact:

    Sara Frith

  • Contact email:

    SaraF@Scantec.co.uk

  • Contact phone:

    +44 (0)151 666 8951

  • Job ref:

    SF-QA-NW

  • Published:

    about 2 months ago

  • Duration:

    n/a

  • Expiry date:

    2018-03-29

  • Start date:

    asap

A leading FMCG Manufacturer is currently recruiting for a Quality Manager to support the Head of Quality in the development implementation, maintenance and continuous improvement of the QMS. This role will require a Medical Device or Pharmaceutical manufacturing background.

Quality Manager responsibilities include:

  • Ensure that compliance with the company’s Specials Manufacturing Licence and Wholesale Distribution Authorisation are maintained and that all applicable company operations and processes conform to the principles of GMP and GDP.
  • Manage and develop the Quality Assurance and Compliance team direct reports.
  • Build strong cross-functional working relationships with manufacturing staff and other departments within the business to engender a Quality Culture.
  • Ensure compliance with current Medical Device regulations and company procedures. To communicate effectively to the relevant regulatory authorities and other stakeholders.
  • Compliance of the site to regulatory standards and ISO9001:2008 by ensuring high quality standards and GMP are maintained.
  • Provide leadership, coaching and guidance to the Quality Assurance and Compliance team to ensure compliance, high quality standards and GMP are maintained.
  • Support the Quality Assurance and Compliance team in developing, implementing, maintaining and continuously improving the Quality Management System.
  • Conduct risk assessments and gap analysis of the current quality systems and formulate actions plans accordingly to continuously improve the Quality Management system.
  • Monitor compliance with the Quality Management System, trend data and implement effective corrective measures as required.
  • Manage non-conformance issues and formulate edicts on the standards that need to be applied to maintain compliance with regulatory expectations.
  • Support Complaint investigation and closure review to maintain compliance with regulatory expectations.
  • Provide Validation support across the business, in line with regulatory requirements.
  • Support the Change Management system to maintain a ‘State of Control’ across the business.
  • Perform and monitor audits both internally and at a partner or supplier operations to support the identification, action and close out of non-compliance issues and to identify areas for continuous improvement.
  • Deputise for the Head of Quality for the review and approval of defined Quality documentation.

You will be a Quality Manager used to working in a Medical Device or Pharmaceutical manufacturing environment.
To apply please contact Sara 0151 6668951

Scantec specialises in the Manufacturing, IT, Technical, Engineering and Scientific Sectors. Scantec provide highly qualified and experienced personnel in a compliant and professional manner on both a permanent and temporary assignment basis.

Due to the high volume of applications Scantec receives it is not always possible to acknowledge every application. Shortlisted applicants will be contacted within 28 days. If you don’t hear from us within 28 days your application has not been shortlisted at this time, to be considered for future vacancies please register with us on our website.