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QA Document Controller  Liverpool United Kingdom

QA Document Controller

Permanent | Wellington House, Physics Road | Liverpool | United Kingdom | L249HP

As Document Controller you will effectively work within the QA department (UK) to ensure both QA regulatory and business requirements are met. You will work with other departments to ensure a strong QA culture throughout the business and providing guidance.

You will provide paper and electronic filing support to the Quality System, final edit issues of Quality Procedures and provide trending data via data analysis of metrics. 

 

Key Accountablities

 

  • Management of Batch Manufacturing record (BMR) generation and approval process in accordance with the weekly plan.
  • Co-ordinate the business document management system ensuring quality standards are maintained, documents are prepared, approved, revised, obsoleted and archived as required, & providing training as necessary
  • Support any site customer & regulatory audit(s)
  • Delivery of annual GxP/new starter training
  • Participate in the continual improvement of the site Quality systems and ensure ongoing compliance in-line with current regulatory requirements
  • Adhere to all business policies & procedures
  • Work closely with the Manufacturing/Warehouse/QC areas of the business to ensure Quality system(s) are maintained/compliant/adhered-to
  • Maintain training Matrix and site Master SOP file and spreadsheet.
  • Maintain site archiving system and archive QA documents as appropriate.
  • Provide office administration duties for Quality Management

 

Skills & Experience

 

  • Demonstrated ability to implement procedures and processes which ensure compliance to GxP and other relevant regulatory standards specific to the Tobacco/Nicotine industry
  • Good oral and written communication skills for effectively interfacing with all levels of management and departments within the global business
  • Time management & able to work on own initiative
  • Good level of IT skills
  • Decisive thinker able to work within agreed timescales
  • Working knowledge of GMP (Good Manufacturing Practice), GDocP (Good Documentation Practices) and PMTA (Pre-Market Tobacco Product
  • Application) TPD (Tobacco Products Directive)
     

Qualifications:

  • Experience handling & maintaining auditable documents
  • Taking part in audit preparations
  • Process work to ISO 9001 standards.
  • Experience of compiling data reports using Microsoft Excel graphical representations
  • Experience in document design and preparation of templates

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