People, Person

Nerudia-520x240.png

QA Engineer

QA Engineer

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

As QA Engineer you will be responsible for maintaining the overall technical quality of product from design to commercialisation ensuring all Innovations R&D and Operations activities are conducted to the agreed GxP, regulatory standards and that safe working practices are current & adhered to.

 

Key Accountablities 

  • Participate in New Product Development (NPI) initiatives by providing quality engineering support to assigned projects
  • Oversee the Product Development Process and ensure defendable practices & scientific analyses are employed
  • Perform document review and approval of all quality impacting documentation 
  • Participate in pilot plant development & technical transfer activities
  • Participate in product Risk Reviews during product development and post-launch activities as well as maintain product Risk Management files
  • Develop NPI Quality Plans
  • Lead process definition and improvement activities and training within the Innovations Operations and R&D functions
  • Provide QA oversight on validation and perform document review and approval of all validation documentation i.e. qualification/validationprotocols, validation plan, supporting documentation e.g. URS, DQ
  • Improve awareness, communication, and training on quality procedures and initiatives 
  • Provide data analysis, trending of processes, products characteristics and other feedback on current product issues or developments
  • Participate in continuous improvement activities in a cross-functional environment (e.g. Kaizen)
  • Maintain and comply with the requirements of ISO9001 and other applicable regulatory requirements
  • Identify areas for improvement of the QMS through active participation in internal audit program
  • Schedule and support audit activities including pre-audit planning, audit readiness and post-audit follow-up with lead auditor

 

Skills & Experience

  • Strong organisational and multi-tasking skills
  • Ability to work effectively in a fast-paced environment & comfortable with continual change
  • Exposure to/ experience with validation is highly advantageous
  • Excellent oral & written communication skills for effectively interfacing with all levels of management and departments within theinternal/external business
  • Strong technical, analytical, and writing skills to identify and solve problems and document them appropriately
  • In-depth knowledge of GxP i.e. GMP (Good Manufacturing Practices), GDocP (Good Documentation Practices) and TPD (Tobacco Products Directive)
  • Excellent project management skills are strongly preferred
  • Good understanding of statistical methods, six sigma methodologies, design of experiments and lean
  • Ability to read technical drawings and experience in writing procedures to QMS requirements
  • Strong ability to manage and prioritise multiple projects while maintaining accuracy and meeting deadlines with the capability to balance short-term, urgent needs with long-term strategic initiatives
  • Systematic problem-solving skills in identifying, prioritising, communicating, and resolving quality issues
  • High attention to detail and processes
  • Goal oriented, interpersonal, self-motivated and team player
  • Knowledge of MS Office (Word, Excel) and other quality tools (Minitab, FMEA, SPC, etc.) and their application
  • Certification in Six Sigma green/ black belt is an advantage
     

Qualifications:

  • Significant experience in a manufacturing environment especially New product Development, Pilot Plant & Technology Transfer
  • Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820 is advantageous
    Degree or higher in engineering or equivalent is desirable

Apply Now

Not ?

Thank you for your interest. We will be in touch.

Other Nerudia Jobs

3rd Line Support Analyst

Liverpool United Kingdom Wellington House, Physics Road, Liverpool, United Kingdom, L249HP Information Technology Associate
As 3rd Line Support Analyst you will support the businesses existing infrastructure including server, storage, network, data and applications as well as project based work to improve and enhance the infrastructure environment.

Health & Safety (H&S) Advisor

Liverpool United Kingdom Wellington House, Physics Road, Liverpool, United Kingdom, L249HP Manufacturing Junior
The role of Health & Safety Advisor is to assist the Health and Safety Manager with day to day health and safety tasks and ensure that the site is compliant with health, safety and environmental standards. He/she will be supporting the developmen...

Head of Quality

Liverpool United Kingdom Wellington House, Physics Road, Liverpool, United Kingdom, L249HP Manufacturing Senior
As Head of Quality you will provide strategic and tactical responsibility for implementing Quality strategy and strategic operational goals (to exceed customer expectations for product quality, cost and delivery) optimising production quality leve...

QA Engineer

Liverpool United Kingdom Wellington House, Physics Road, Liverpool, United Kingdom, L249HP Manufacturing Associate
As QA Engineer you will be responsible for maintaining the overall technical quality of product from design to commercialisation ensuring all Innovations R&D and Operations activities are conducted to the agreed GxP, regulatory standards and that ...

Warehouse Manager

Liverpool United Kingdom Wellington House, Physics Road, Liverpool, United Kingdom, L249HP Manufacturing Senior
As Warehouse Manager you'll be responsible for ensuring the effective management of goods in, warehousing, despatch and stock. You will also oversee Warehouse functions to ensure the business achieves it Key Performance Indicator (KPI) targets a...

Laboratory Manager - Next Generation Product (NGP)

Liverpool United Kingdom Wellington House, Physics Road, Liverpool, United Kingdom, L249HP Research Development Senior
As Laboratory Manager you will provide Next Generation Product (NGP) QC Operational/Innovations leadership. Ensuring all laboratory activities (Operational/Innovations) are conducted to the agreed regulatory standards. You will lead development ...

Job Alerts

Not ?

Thank you