Validation Officer

  • Salary: Competitive
  • REF Number: 00053701
  • Consultant: Sarah Farrow
  • Contact: 0191 3706486
  • Date Published: 20.05.2022
  • Closed Date: 23.06.2022
  • Industry: Pharmaceutical
  • Location: Burnopfield, North East
  • Functional Expertise: Quality, Engineering

CK group are recruiting for a Validation Officer on behalf of a busy Pharmaceutical Manufacturing company, to be based at their site in Co. Durham on a permanent basis.

The main purpose of this role is to assist with validation activities, in order to ensure regulatory compliance with GMP and GDP and internal policies and procedures.

Your responsibilities will include:

  • Acting as the validation representative on project teams
  • Assisting the Validation Manager with the Site ValidationMaster Plan (SVMP) activities to ensure continual compliance, by working with multi-disciplinary teams across site
  • Ensuring that the manufacturing facilities (aseptic and non-sterile), process, equipment and computer systems are validated in fullcompliance with GMP, GDP and regulatory requirements so as to meet the stipulated product quality, patient safety & data integrity standards in line with established specifications or requirements of the organisation
  • Assisting with the introduction of new equipment, processes and systems through the creation of technical documentation including, but not limited to VP, URS, IQ, OQ and PQ
  • Ensuring that all stages of the validation lifecycle are met with new and existing equipment, processesand computer systems
  • Working closely with the Validation Manager and Operations to develop and maintain a Cleaning Validation / Verification package for all product contact equipment and manage the ‘live’ cleaning validation matrix
  • Acting as author or validation technical reviewer of validation documents
  • Supporting the operational teams on existing and future validation projects
  • Ensuring that all validation projects are performed in line with the documentation requirements of the validation system, including quality risk management principles
  • Assisting with training in validation procedures
  • Providing consistent validation advice to key stakeholders
  • Producing data and reports on performance, measuring against set key performance indicators
  • Ensuring that regulatory changes which have an impact to validation are appropriately assessed for their impact on the business
  • Deputising for the Validation Manager, when required

To be considered for the position youshould have the following skills and experience:

  • Experience of working in a Validation role in a relevant industry
  • Experience of working in a Pharmaceutical environment would be highly beneficial for this position
  • Experience of Computer System Validation (CSV) would be highly beneficial, although not essential

The benefits include: Generous holiday entitlement Free fruit, bread and jams onsite, Eye care vouchers, Active social and charity committees

Apply: For more information, or to apply for the position, please contact Sarah Farrow on 0191 3706486 or email sfarrow@ckgroup.co.uk. Please quote job reference 53701.

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