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Facility and Validation Manager

J4 RESOURCING LTD
Job LocationNottingham
EducationNot Mentioned
Salary50,000 - 60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Role The Facility and Validation Manager is responsible for the organisation GMP facility and equipment operations including Maintenance, Calibration, and Qualification. The role is also responsible for the development and implementation of the strategies forthe qualification of the manufacturing facility and equipment including strategy implementation, execution and compliance to GMP. The post holder will ensure that all operations are conducted within the framework of the Quality Management System and that theymeet regulatory requirements.Job Specific Responsibilities

  • Ensure that the facility is maintained to a state that meets all regulatory and client expectations.
  • Responsible for implementation of the Quality system covering all activities within Engineering and qualification.
  • Ensuring that all activities and outputs meet the business quality system.
  • Support all scale up and production activities to ensure that project deliverables and targets are successfully met and are of the highest quality.
  • Manage and structure Engineering staff and contractors and be responsible for their performance, training and regular appraisal.
  • Responsible for planning and implementing the Maintenance budget.
  • Responsible for the GMP facility and equipment within it
  • Ensure that all equipment and facility documentation emanating from the GMP facility and equipment meets the requirement of the business Quality system including equipment records, maintenance records / technical instructions.
  • Lead the validation / requalification activities as part of the Quality Management System, utilising the team and engaging the support from specialist contractor(s) as required.
  • Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
  • Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities for all new and existing plant and equipment.
  • Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
  • In addition to the contractors, manage other validation team member(s), including their performance, development, training, and compliance.
  • As a key member of the GMP team, contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external stakeholders.
  • Draft and review GMP documentation including validation documentation, SOPs, and training documentation.
  • Train team members in procedures relating to validation as required.
  • Understand the production schedule and work closely with Manufacturing to build a qualification schedule that delivers minimum interruption to manufacturing output.

Keyskills :
GMPValidationSATsFATs

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