Stewart Manegold
Quality & Regulatory Manager at Nordic Pharma UK- Claim this Profile
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English -
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Bio
Experience
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Nordic Pharma UK
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United Kingdom
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Quality & Regulatory Manager
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Nov 2022 - Present
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PARAPHARM DEVELOPMENT LIMITED
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United Kingdom
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Pharmaceutical Manufacturing
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1 - 100 Employee
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QA and Regulatory Conformance Manager
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Nov 2020 - Nov 2022
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inglasia pharma solutions
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United Kingdom
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Quality Consultant
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Sep 2020 - Nov 2022
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Crescent Pharma Ltd
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United Kingdom
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Head Of Quality
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Mar 2016 - Nov 2020
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Quality Manager
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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
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Pharmaceutical consultant
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Pharmaceutical Consultant
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Jun 2014 - Feb 2016
Providing quality assurance services to the pharmaceutical industry Providing quality assurance services to the pharmaceutical industry
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Local Energy Ltd
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United Kingdom
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Mining
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Energy Efficiency Project Manager
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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
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South England
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United Kingdom
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WINACC Information Officer
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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)
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B&Q
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Belgium
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Sustainability Volunteer
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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
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sanofi-aventis
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France
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Quality Systems Manager
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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
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Senior Quality Auditor
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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
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Cardinal Health
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United States
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Hospitals and Health Care
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700 & Above Employee
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Project Team Member
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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.
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Quality Systems
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Egypt
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Retail Office Equipment
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1 - 100 Employee
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Section Head
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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.
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Packaging & Release Officer
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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.
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Quality Assurance Officer
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Sep 1986 - Oct 1991
Microbiology technician analysing sterile and non-sterile medical preparations Microbiology technician analysing sterile and non-sterile medical preparations
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NETHRA
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India
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Machinery Manufacturing
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1 - 100 Employee
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Microbiology technician
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Jun 1986 - Sep 1986
Microbiology Technician Microbiology Technician
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Education
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Staffordshire University
PGDip, Sustainability and Environmental Management -
University of Brighton
PGDip, Pharmaceutical science -
Liverpool John Moores University
BSc, Applied Biology