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Job

Commissioning and Qualification Lead

  • Location

    Belgium

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    €110 - €115 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.

 

Requirements:

  • Degree in Engineering preferred
  • Pharma experience preferred
  • Has excellent interpersonal and communication skills
  • Has excellent 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
  • Has relevant technical expertise (DCS systems, preferable Emerson DeltaV ; Batch Control ; ISA S88)
  • Knowledge about GAMP 5 preferred
  • Has Operational / Plant Safety experience and a ‘Safety First’ mindset!
  • Has GDP/GMP experience and mindset!
  • Fluent in English, Dutch language preferred
  • Has vast Project Delivery, Validation, C&Q experience (equipment/process/E&I/DCS)

 

Responsibilities:

  • Will report to the project’s Execution Systems Lead
  • Overall co-ordination of all project validation deliverables / test stages whereby leading a team of C&Q Leads (C&Q Document Lead, C&Q Execution Lead)
  • Engaging with Execution Systems, Operations, Technical Operations, Software, Equipment, Validation and QA SME’s / project team members in support of completing the E2E Validation / Test Stages of the project
  • Driving / leading the validation plan E2E with key focus on safety, quality and schedule attainment:

HAT, SIT, IQ, SW FAT, Commissioning, Qualification (IQ, OQ, PQ)

Impact Assessments, Risk Assessments, Design Review, Requirements Traceability Matrix

Deviation & Change Management

Configuration Management

Equivalency / Leveraging Management

Pro-actively tracking and steering all prerequisites leading into each test stages, and this for multiple parallel test streams

Drive planning, scheduling and tracking of schedule

Resolve problems in a compliant manner before they stop the project

 

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/.