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Validation Specialist

Job Title: Validation Specialist
Contract Type: Permanent
Location: Radlett, Hertfordshire
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: J895552_1529308692
Contact Name: Danny Speed
Contact Email: danny.speed@russell-taylor.co.uk
Job Published: June 18, 2018 08:58

Job Description

Validation Specialist - Sterilisation

Type: Permanent

Location: Hertfordshire/ Bedfordshire

Our Client - a leading Pharmaceutical company are looking to appoint an experienced Validation Specialist to work at their prestigious site; the successful candidate will be given the chance to work with some of the best technologies and will be offered further career scope in the growing validation/ process improvement team.

Reports to Validation Manager

The Role:

  • Ensuring compliance with all applicable (EHS and GxP) regu latory and internal QMS standards and industry best practice.
  • Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle; so that they are understood/ transparent and can be managed through the application of a quality risk management approach.
  • You need to be committed to, and passionate about providing a reliable and compliant service to meet and exceed the customer's needs. This is a customer-facing role, and as such the ability to form relationships across the organisation is essential for success.
  • Collective responsibility for the ongoing compliance of all assets at the different sites within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
  • Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
  • Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.

Essential Skills :

  • Must have worked within a in Sterilisation Validation (SIP)
  • In depth knowledge of the requirements of EN285 and its practical application when validating porous load sterilisers.
  • In depth knowledge of the requirements and expectations associated with depyrogenation validation.
  • In depth knowledge of the requirements and expectations associated with Hydrogen Peroxide bio decontamination.
  • Fully conversant in the requirement and expectations around cycle/load development and worst case challenging of sterilisation/depyrogenation/bio decontamination processes.
  • Practical hands-on experience of executing sterilisation/depyrogenation/bio decontamination validations.
  • You understand, can clearly explain and would be able to train others sterilisation/depyrogenation/bio decontamination validation.

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