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Validation Co-Ordinator

Kent   •  £30000 - £40000 per annum  •  Permanent, Full time


A global pharmaceutical company requires a Validation Co-Ordinator to join its team. You will oversee all validation activities with a primary focus on equipment and cleaning validation. You must have previous validation experience including creating protocols and writing high-quality reports. Those from the food, pharma or related industries will be considered.

JOB DESCRIPTION SUMMARY

This position is responsible for overseeing all validation activities. This includes assessing all projects to ensure appropriate qualification occurs prior to initial production use, ensuring all deviations are resolved and clearly documented, and appropriate procedures are written or updated to account for the equipment, process, or system. This position reports to the Regulatory Affairs and Quality Assurance Manager.

MAIN RESPONSIBILITIES:

  • This role must maintain and update the Site Validation Master Plan and document as required to accommodate changes at the Dartford site.
  • Creation of new Project Numbers across site with the exclusion of Global Quality Assurance.
  • Maintenance of the Validation Database during and after the lifecycle of any given project within the Oracle system
  • Manage Qualification/Validation of Plant based activities, Processes, Cleaning Validation and Equipment as required.
  • Ensures all Plant based activities, established through Qualification / Validation, are discussed with all associated staff and procedures / instructions are in place to ensure compliance with requirements.
  • Ensure all processes introduced provide Plant compliance with Good Manufacturing Practice (GMP) and Environment, Health and Safety (EHS) policy as well as all other general requirements.
  • Reviews / Approves all (with the exception of Global Quality Assurance), validation Protocols and Reports prior to final execution and sign-off.
  • Maintains the periodic evaluation schedule by updating validation projects in Oracle and monitoring the Site Re-Validation Assessment within the Business Intelligence Database.

EXPERIENCE REQUIRED

  • BSc in relevant science-based subject or equivalent experience
  • Experience working in production departments of pharmaceutical, excipient, chemical or food industries and of IQ/OQ/PQ validation and/or qualification from these industries.
  • Creating and writing validation protocols and reports, in word and excel. Good eye for detail, people skills (requirement to work closely with production operatives and other department)
  • Working at Dartford site for normal office hours and from home. A degree of flexibility is required as some validation batches may be made outside of normal office hours and they will need to be monitored. Some overseas travel may be required
  • Self-motivated individual with an ability to assess the scale of the project, plan the work and a desire to get the job done. Motivate others, exercise diplomacy and strong attention to detail.


You must have the right to work in the UK. Learn more

  • Agency: Cranleigh Scientific
  • Reference: 7437
  • Posted: 14th July 2022
  • Expires: 11th August 2022

Cranleigh Scientific

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