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Quality Engineer

Atom Recruitment Ltd.
Job LocationGreat Yarmouth
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Our Client is a very successful pharmaceutical manufacturing company. They are now seeking a Quality Engineer. This position is a full-time permanent role and will be based in Great Yarmouth.Key Areas of Responsibility

  • Work with the wider validation team to coordinate required validation & revalidation activities of all applicable GMP equipment including new equipment and facilities
  • Assist the Engineering Management Team to ensure all engineering and engineering tasks on validation related Change Controls & CAPAs are completed
  • Complete or coordinate all Engineering quality documentation as related to the site validation strategy across engineering projects including facilities, equipment, processes, and services
  • Working collaboratively with all departments, produce and execute validation protocols, develop equipment validation/qualification requirements (DQ, IQ, OQ, PQ and cleaning validations)
  • Liaising with the Computer System Validation team to ensure such aspects are covered during the execution of protocols
  • Maintaining validation registers to provide overview of validation status. Prepare validation summary reports for completed projects. Working closely with the QA Manager responsible for oversight of validation processes
  • Coordinate directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols
  • Develop timelines for the validation requirements of all projects and ensure that deadlines and goals are being met. Provide frequent updates to management and team on progress
  • Provides resource and expertise in the management of change controls relating to engineering projects
  • Assist in the creation and completion of risk assessments, FMEA and Root Cause Analysis related to validation
  • Support continuous improvement projects relating to both sustaining engineering and product development activities
Qualifications / Experience
  • Degree level (or equivalent) qualifications in either Science, Engineering or Manufacturing Technology
  • Previous experience of validation processes, change control and risk management, gained within the Pharmaceutical or Medical Device industry.
  • Ability to demonstrate solid direct experience in validation
  • Knowledge of cGMP and/or ISO13485
  • Excellent verbal & written communication skills with the ability to present complex issues in a clear, logical, and persuasive way
  • Strong organisational and project management skills, with the ability to handle a broad range of responsibilities and multiple priorities and projects
  • Excellent internal and external relationship management skills to work collaboratively and influence cross-functional teams
  • Enthusiasm in the pursuit of engineering and production quality and performance perfection
  • A proven track record of problem solving and decision making with proactive identification of improvements
In return our client is offering a competitive salary and benefits package for the successful CandidatePlease send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.

Keyskills :
GMPPharmaceuticalValidationMicrosoft Certified Systems EngineerQuality

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