Quality Assurance Engineer

Recruiter
VQ Life Sciences
Location
Lancashire
Salary
Competitive
Posted
10 Jul 2019
Closes
13 Jul 2019
Contract Type
Permanent
Hours
Full Time

VQ Life Sciences are recruiting for a Permanent QA Engineer based in the Northwest.

Job Purpose

  • Maintains 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 at all times

Specific Responsibilities

Responsibilities of a QA Engineer include but are not limited to the following:

  • 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 (incl. engineering)
  • 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 ie qualification/validation protocols, validation plan, supporting documentation eg URS, DQ
  • Improve awareness, communication, and training on quality procedures and initiatives to support corporate quality goals
  • Provide data analysis, trending of processes, products characteristics and other feedback on current product issues or developments to the business
  • Participate in continuous improvement activities in a cross-functional environment (eg 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
  • Any other duties as assigned

KPI Areas/Measures of Performance

  • Internal & external audit performance ie Regulatory & Customer
  • Feedback from 1-2-1's & annual performance review

Experience & qualifications required

  • 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 the internal/external business
  • Strong technical, analytical, and writing skills to identify and solve problems and document them appropriately
  • In-depth knowledge of GxP ie 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:

  • At least 5+ years of related 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

If you have the relevant experience and interested in this Permanent QA Engineer position in the Northwest please apply.

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