Jobs

    Qualified Person - Manchester, United Kingdom - Albion Rye Associates

    Albion Rye Associates
    Albion Rye Associates Manchester, United Kingdom

    Found in: beBee S2 UK - 5 days ago

    Default job background
    Full time
    Description

    Job title: Qualified Person

    Salary: £100,000+ Basic plus market leading package

    Do you have the skills to fill this role Read the complete details below, and make your application today.

    Site commutable from: Manchester, Liverpool, Blackburn, Burnley, Wigan, Leeds, Huddersfield, Bradford, Halifax & Harrogate.

    Albion Rye Associates are working in partnership with a globally recognised market leader in their space to recruit a Qualified Person (QP) for their site in the North of England.

    Responsibilities:

  • Defining GxP protocols and benchmarks for the facility in conjunction with the divisional Quality unit and external stakeholders, overseeing gap analyses, and spearheading enhancement initiatives as needed.
  • Offering Quality guidance to teams working on FMEA, root cause analysis, and other investigative methodologies to ensure a comprehensive and systemic quality ethos permeates all operations.
  • Promptly reporting trends and quality concerns uncovered during batch evaluations, systemic anomalies, or operational observations to the Head of Quality.
  • Conducting QP batch certification for authorized pharmaceuticals (in accordance with relevant regulations) and delivering QP assistance as necessary for plant-related issues, expert evaluations, annual reviews, and documentation supporting licensure submissions/variations and product clearance.
  • Collaborating with Group Regulatory Affairs to provide authoritative GMP counsel for new submissions and modifications/supplements.
  • Participating in internal and external audits, and aiding in vendor quality oversight endeavors at both local and divisional tiers.
  • Contributing to internal and external inspections by regulatory agencies (UK, US, EU, etc.).Requirements:
  • Eligibility to perform the duties of a Qualified Person
  • Extensive background in the pharmaceutical quality sector.
  • Comprehensive understanding of approved products, procedures, and regulatory frameworks.
  • Prior engagement with MHRA/VMD, FDA, and involvement in regulatory inspections.
  • Thorough grasp of global pharmaceutical regulations. If you are an Eligible QP looking for a new challenge, drop me a message Would be more than happy to discuss more and understand if this could be a good fit for yourself. ???? ????

  • Albion Rye Associates

    Qualified Person

    Found in: Ziprecruiter UK C2 - 4 days ago


    Albion Rye Associates Manchester, United Kingdom

    Job Description · Job title: Qualified Person · Salary: £100,000+ Basic plus market leading package · Site commutable from: Manchester, Liverpool, Blackburn, Burnley, Wigan, Leeds, Huddersfield, Bradford, Halifax & Harrogate. · Albion Rye Associates are working in partnership w ...

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