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Senior QA Officer  Liverpool United Kingdom

Senior QA Officer

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

As QA Officer you will provide direct support to the QA Manager in the management of the day to day aspects of the global QA function, including deviation close out and associated investigations as well as conducting self-inspections, supporting the Product Quality Review (PQR), Change Control (CC) processes and participating in quality based projects.

Driving continuous improvement activities via development/enhancement and implementation of the business Quality Systems in order to maintain a fully compliant facility.   You'll effectively work within the global business to ensure both quality & regulatory requirements are met at all times
and work with other departments to ensure a strong QA culture throughout the business and providing guidance.  

You will deputise for the QA Manager when required.

Key Accountabilities 

  • Review external (global) Batch Manufacturing Records (BMR) and provide timely documented feedback for corrections / amendments to ensure any fixed product release dates are adhered
  • Reinforce the global quality principles & provides independent assurance of the maintenance of the global quality systems/standard(s)
  • Timely and effective resolution of all quality issues to maintain product flow across the global business
  • Support business to make global product & material release decisions
  • Ensure global compliance within the change management, CAPA & deviation processes to drive efficient resolution
  • Global planning & support internal/external inspection preparations as well as significant audits to aid in developing improvement plans. Follow up any actions to ensure ongoing compliance
  • Providing global business expert advice on GxP relevant to current Nicotine/Tobacco regulatory/standards 
  • Advise global business on deviations / change controls etc. using professional judgment to make batch disposition recommendations to approve or reject product with global QA management guidance
  • Supporting global supplier/customer complaint investigations and approving investigation reports
  • Leading formal and informal training of less experienced business members and/or new starters to meet global business needs, including GxP training.
  • Assist with global qualification/validation review/approval activities
  • Manage the coordination of the global business document management system ensuring quality standards are maintained, documents are prepared, approved, revised, obsoleted and archived as required, and providing training as necessary
  • To participate in the continual improvement of the global Quality system(s) and ensure ongoing compliance in line with regulatory/standard requirements
  • Adhere to all global business policies & procedures
  • Ensure adequate QA support for the global business to ensure Quality system(s) are maintained/compliant/adhered-to

 

Skills & Experience 

  • Substantial experience, preferably within a senior role, of working in a Quality Assurance related role in a Pharmaceutical or similar industry
  • Demonstrated ability to implement procedures and processes which ensure compliance to GxP and other relevant regulatory standards specific to the Tobacco/Nicotine industry
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within a global business
  • Strong technical, analytical, and writing skills to identify and solve problems and document them appropriately
  • Effective time management & able to work on own initiative
  • Excellent level of IT skills
  • Decisive/innovative thinker able to work within fast paced timescales
  • Experience of leading quality based investigations & root cause analysis on a global platform
  • Working knowledge of GMP (Good Manufacturing Practice), GDocP (Good Documentation Practices) and PMTA (Pre-Market Tobacco Product Application) TPD (Tobacco Products Directive)

 

Qualifications:

  • At least 5+ years’ relevant experience in a quality, documentation, or project management role or combination thereof within a pharmaceutical or similar development setting required
  • Area of expertise preferred:  Quality, GxP, Regulatory and/or Nicotine products
  • Higher National Certificate or higher in Biology, Chemistry, Pharmaceutical Sciences, or related scientific discipline is desirable

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