QA Officer - Newcastle upon Tyne, United Kingdom - Immunodiagnostics System Ltd

Immunodiagnostics System Ltd
Immunodiagnostics System Ltd
Verified Company
Newcastle upon Tyne, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description

QA Officer

QA/RA - UK
IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients.
IDS Boldon is the global IDS Headquarters occupying a single, multi-disciplined site.
The site focuses on the manufacture and distribution of manual Immunoassay products.

On site Purchasing, Logistics, Production, Quality Control and Process Development departments manage the supply chain, supported by local Sales Support, Quality Assurance, Regulatory Affairs and Finance departments.

As Group Headquarters, IDS Boldon also houses all head office functions.


Job Purpose
Assist in the maintenance of the IDS Boldon Quality Management System; and to ensure that manufactured product (IVD) is manufactured and distributed in accordance with the appropriate International Standards & Regulations

Principal Accountabilities

  • Assist in the management of the IDS Boldon Quality Management System in accordance with appropriate International Standards & Regulations and Group Standards for the manufacture of IVD products at IDS Boldon.
  • Complete reviews of batch manufacturing records to ensure adherence to requirements leading to the QA Release of intermediate and final product at IDS Boldon.
  • Interface with R&D and Operations departments to ensure the efficient and compliant transfer of new products from R&D to IDS Boldon Production.
  • Ensure that products and processes comply with the relevant requirements of the quality management system.
  • Evaluate and continually improve Quality Systems to ensure that products and processes meet defined quality standards and comply with the appropriate international standards and regulations.
  • Facilitation of nonconformance investigation, root cause analysis and implementation of effective CAPA for process related concerns.
  • Assessment and approval of changes to ensure quality impact analysis, risk management and validation activities are identified and carried out.
  • Conduct internal quality audits and assist with external audits
  • Assist in the investigation and analysis of failure, corrective and preventive action to respond to customer complaints. Including assessment of potential reportable events.
  • Creation, maintenance and approval of all QMS documentation
  • Completion and analysis of QA Metrics towards Quality Management Reviews
  • QMS document control, including archiving & periodic reviews
  • Deputise for QA Lead
  • Ensuring the promotion of quality awareness throughout the Company
  • Deliver training to build quality awareness
  • Release of quarantined materials
  • Supplier/Distributor assessment, approval and reevaluation
  • Review, approval and administration of Product Notifications
  • Preparation of Post Market Surveillance Reports
  • Administration of online training system
  • Carry out any additional duties as required in support of the normal business activities
  • Monitor the progress of quality activities on a daily/weekly basis ensuring that there is continuous drive/focus on meeting target dates and KPIs
  • Assist with the preparation, execution and completion of validation documentation ensuring compliance to all relevant Quality Standards and Regulatory requirements.
  • Compilation of Euratom returns as required

Skills, Knowledge and Experience

Qualifications

  • GCSE level or higher q
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