Cleaning Validation Specialist

• Reference: JLSCVS
• Location: South Wales
• Salary: £40000
• Type: Full time
• Start: ASAP
• Duration: Twelve Months

Just Life Sciences are seeking a Cleaning Validation Specialist for a FTC of 12 months.

The purpose of the role is

To partake in Risk Assessments and Change Impact Assessments associated with GxP impacting systems, ensuring a suitable approach to Cleaning Validation is established.

To ensure the documentation utilised for Cleaning Validation has been generated in compliance with Statutory, Regulatory, Client and Company expectations.

To work closely with Project Management Teams in Analytical Services, Pharmaceutical Development, Technical Affairs, Operations (inclusive of Engineering), Supply Chain and Clients to ensure projects are progressed in a timely manner.

To provide support with investigations / discrepancies relating to the cleaning of GxP systems and lead any improvement opportunities identified for cleaning practices, ensuring continuous improve techniques are successfully implemented.

To support the execution of Cleaning Validation studies, ensuring:

Qualifications, Skills and Experience

• All activities are completed in a GxP compliant manner.
• Standard Operating Procedures (SOPs) and Work Instructions (WIs) associated with the Validation study are available and adequate for their intended use.
• Training of Key personnel has been conducted and recorded within the training management system.
• All equipment used during a Cleaning Validation study is appropriately qualified and where appropriate calibrated to a recognisable international / national standard.
• Any deviation to the acceptance criteria associated with a Cleaning Validation study is adequately documented and an action plan agreed as required.
• All key findings are adequately reported, concluding whether the Cleaning Validation study has been successful and whether the process is appropriate for routine GxP use.
• To ensure the Site Validation Master Plan is adhered to and maintained in accordance with a risk based, lifecycle approach.
• To be a Subject Matter Expert in Cleaning Validation, and be able to represent the group at client facing meetings and at audit in this discipline.
• To act in a professional manner at all times when liaising with group's client base, to sustain a working environment that promotes the group's Values and Behaviours.
• To ensure a Continuous Improvement ethos is upheld, periodically reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), Templates and Forms with the purpose of standardising and optimising the Validation approach, whilst still maintaining Regulatory compliance.
• To support with the execution and closure of Validation Studies relating to other Validation disciplines (including; Equipment Qualification, Facility Qualification, Utility Qualification and Computer Systems Validation) when deemed as appropriate by the Validation Manager.
• Ideally you will have at least 2 years within a Cleaning Validation position within Pharma including the manufacture and packaging of products.
• If you have the relevant experience and are able to commit to a 12 month Fixed Term contract then please apply to justyn at justlifesciences dot com

Apply Now

• Just Life Sciences

  • 2a Foster Drive,
    Cardiff,
    CF23 9BZ
  • Mobile 07968 551450
  • Email justyn.withey@justlifesciences.com
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