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Job

Quality Assurance Engineer

  • Location

    Belgium

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    Up to €85 p/h

  • Contact:

    Ellen Hickey

  • Contact email:

    e.hickey@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Duration:

    6 months

  • Expiry date:

    2019-03-10

  • Startdate:

    ASAP

Do you want to be a part of a pharmaceutical company that has global recognition and is widely admired? Is it important to you to be part of a motivated team; striving to provide and improve global medicines?

This pharmaceutical organisation is rated as one of the best in the world according to FORTUNE magazine’s annual World’s Most Admired Companies list. They are an exciting and innovative company; for the fourth consecutive time they ranked among the top three companies working to expand global access to medicines on the 2018 Access to Medicine Index.

 

Responsibilities:

  • Will report to the project’s QA Lead
  • Review and approval of validation / qualification related plans, reports, impact assessments, risk assessments, protocols, test forms, deviations, project changes for FAT, HAT, SIT, commissioning, IQ, OQ, PQ focused on software/equipment/process
  • Ensure Janssen Quality standards and procedures are adhered to
  • Engaging with Operations, Technical Operations, Software, Equipment, and Validation SME’s / project team members in support of progressing / completing the qualification stages during the migration

 

Requirements:

  • Pharma experience preferred
  • Has good interpersonal and communication skills
  • Has good teamworking skills
  • Can demonstrate a pro-active behavior, seeing potential issues / risks / opportunities and translate these into mitigations / solutions / improvements
  • Can work well under pressure
  • Relevant technical expertise preferred (DCS systems, preferable Emerson DeltaV; Batch Control ; ISA S88)
  • Knowledge about GAMP 5 preferred
  • Has GDP/GMP experience and mindset
  • Dutch language
  • Has QA experience (equipment/process/E&I/DCS)
  • Has experience with QA related tasks with regards to the Validation of DCS systems on (pharm) equipment & processes, ranging from validation master plan, impact assessments, risk assessments, URS, FRS, FS, hardware acceptance testing, site installation testing, software acceptance testing, commissioning & qualification (IQ, OQ, PQ)

 

Apply Now

You can apply for this role by sending us your CV or by calling us now!

Ellen Hickey

Specialist Validation & C&Q Recruiter

Contact: 0203 675 2956 or email e.hickey@hamlynwilliams.com.

We recruit for a variety of opportunities in Life Sciences so feel free to get in touch with us to find out how we can help you. 

You can learn more about me by looking me up on LinkedIn. Search for Ellen Hickey https://www.linkedin.com/in/ellen-hickey-609a33b7/.