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13 Feb 2018

Process Validation(Dry Fog)

Competitive salary

Belgium

Salary

Competitive salary

Currency

GBP

Type

Contract

Ref No

1201

Date Posted

13-Feb-18

My client science-led global healthcare company in Belgium are looking for an experience Quality Assurance consultant with 2 years experience in field of Validation and 1 minimum on the validation of a dry fog or VHP system (Equipment qualification + validation of decontamination) to join their Aseptic & Bioprocess business unit which is made up of the injectable forms departments, Bioplant and development laboratories.

 

The assignment would be a daily rate assignment where the client expects the ideal candidate to be available within 2 weeks

Main Duties involved:

To ensure the qualification (from the Design phase until the end of Validation) of equipment, premises, computerized and utilitarian systems in compliance with the Good Manufacturing Practices and the rules of hygiene and safety and in accordance with Validation Master Site System Plans. Guarantee permanent auditability of the validation and qualification files of the installations

This translates into the following operational activities:

  • Define and monitor the qualification / validation strategies of facilities and manufacturing processes.
  • Writing the qualification / validation documents in compliance with Good Manufacturing Practice(GMP)
  • Execute and / or verify the qualification tests of installations and utilities (eg HVAC, thermal validation) by involving future users and in accordance with the procedures in force.
  • Be a force for proposing innovative solutions that are compatible with the various pharmaceutical requirements in force


Specific professional / technical expertise and key skills required:

  • Minimum 2 years of experience in the field of validation and 1 minimum experience on the validation of a dry fog or VHP system (equipment qualification + validation of decontamination)
  • Knowledge of pharmaceutical industrial processes (bioreactors, CIP, SIP, media simulation)
  • Knowledge of techniques in IT / Computer System Validation
  • GMP and CFR,
  • Ability to take responsibilities and decisions,
  • Knowledge of languages: English, French,
  • Ability to manage contacts with internal customers and external suppliers.
  • Ability to be innovative, Entrepreneurship
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