Stewart Manegold

Quality & Regulatory Manager at Nordic Pharma UK
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Greater Southampton Area, UK
Languages
  • English -

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
You need to have a working account to view this content.

Experience

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality & Regulatory Manager
      • Nov 2022 - Present
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QA and Regulatory Conformance Manager
      • Nov 2020 - Nov 2022
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Consultant
      • Sep 2020 - Nov 2022
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Head Of Quality
      • Mar 2016 - Nov 2020

    • Quality Manager
      • Dec 2015 - Mar 2016

      Notice to Recruiters - For new positions within Crescent Pharma Ltd please contact Julia Allwoood at jallwood@crescentpharma.comTo lead and manage the strategic and operational performance of the Quality Department, ensuring the successful delivery of business strategy, Key performance indicators and objectives, whilst adhering to regulatory compliance and achieving commercial success..To ensure the efficient and effective day to day running of the department.Responsibilities:Develop and implement the Quality dept strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.Implement and monitoring all QA systems to ensure compliance with EU directive 2003/94/EC, covering GMP for medicinal products for human use and IMPs for human use.Implement and maintain a quality risk management system to endure risks are adequately controlled in accordance with current requirements .Coordinating MHRA inspections Show less

    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Pharmaceutical Consultant
      • Jun 2014 - Feb 2016

      Providing quality assurance services to the pharmaceutical industry Providing quality assurance services to the pharmaceutical industry

    • United Kingdom
    • Mining
    • Energy Efficiency Project Manager
      • Aug 2014 - Sep 2015

      Managing energy efficiency installations on domestic properties within the Eastleigh Borough District Council area. Recruiting and managing installers Managing energy efficiency installations on domestic properties within the Eastleigh Borough District Council area. Recruiting and managing installers

    • United Kingdom
    • WINACC Information Officer
      • Feb 2013 - Jun 2013

      Informing the general public about the Green Deal through Winchester Action on Climate Change(WinACC) Informing the general public about the Green Deal through Winchester Action on Climate Change(WinACC)

    • Belgium
    • Sustainability Volunteer
      • Oct 2011 - Mar 2012

      Helped with 22nd Century House project - helping find links to Health and Social sectors Helped with 22nd Century House project - helping find links to Health and Social sectors

    • France
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Systems Manager
      • Mar 2005 - Sep 2011

      Managed controlled document system Managed CAPA, Deviation and Change control systems Supported regulatory inspections by MHRA Managed and supports new and existing software project validation Managed CE registration of some medical devices Prepared sustainability presentation for NHS contracts Managed controlled document system Managed CAPA, Deviation and Change control systems Supported regulatory inspections by MHRA Managed and supports new and existing software project validation Managed CE registration of some medical devices Prepared sustainability presentation for NHS contracts

    • Senior Quality Auditor
      • Aug 2003 - Dec 2004

      Managing and developing policy for all auditing activities on site (Internal, Supplier and Customer audits). Key member of corporate team set up to rationalise supplier auditing across the Cardinal Health company by standardising procedure, establishing sharing of data and removing duplication. Establishing and following-up of audit recommendations and corrective action plans. Investigating and reporting on quality failures in production and from customer complaints. Supporting JD Edwards's activities across the site Quality function. Show less

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Project Team Member
      • Sep 2002 - Aug 2003

      Key member of team representing the Quality department helping team to successfully implement JD Edwards ERP system on time, meeting the required cGMP standards. Key member of team representing the Quality department helping team to successfully implement JD Edwards ERP system on time, meeting the required cGMP standards.

    • Egypt
    • Retail Office Equipment
    • 1 - 100 Employee
    • Section Head
      • Nov 1993 - Sep 2002

      Managing company self-audit programme and auditing raw material, packaging component and pharmaceutical contract companies. Managing company corrective action system. Review and approval of IQ/OQ/PQ validation activities in production and laboratory facilities. Ensuring all quality failures were fully investigated and recommendations for improvement were implemented. Managing company self-audit programme and auditing raw material, packaging component and pharmaceutical contract companies. Managing company corrective action system. Review and approval of IQ/OQ/PQ validation activities in production and laboratory facilities. Ensuring all quality failures were fully investigated and recommendations for improvement were implemented.

    • Packaging & Release Officer
      • Oct 1991 - Nov 1993

      Providing a QA service to the packaging department such that GMP standards were maintained and products were released to the market in a controlled and timely manner. Responsible for matters relating to statistical process control. Deputising for Quality Compliance Manager. Providing a QA service to the packaging department such that GMP standards were maintained and products were released to the market in a controlled and timely manner. Responsible for matters relating to statistical process control. Deputising for Quality Compliance Manager.

    • Quality Assurance Officer
      • Sep 1986 - Oct 1991

      Microbiology technician analysing sterile and non-sterile medical preparations Microbiology technician analysing sterile and non-sterile medical preparations

    • India
    • Machinery Manufacturing
    • 1 - 100 Employee
    • Microbiology technician
      • Jun 1986 - Sep 1986

      Microbiology Technician Microbiology Technician

Education

  • Staffordshire University
    PGDip, Sustainability and Environmental Management
    2006 - 2009
  • University of Brighton
    PGDip, Pharmaceutical science
    1991 - 1993
  • Liverpool John Moores University
    BSc, Applied Biology
    1982 - 1986

Community

You need to have a working account to view this content. Click here to join now