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Job ID :
61737BR
Location :
United Kingdom - Horsham
:
Job Description

Position Summary:

  • To support QA / Facilities and Engineering validation / qualification and change control activities for FCS Horsham
  • To provide support to the compliance function as required
  • To write / review and triage investigations and Change Controls from Facilities and Engineering departments
  • Manage, develop and implement qualification protocols and test procedures to ensure equipment and facilities operate correctly and meet applicable GXP requirements
  • Assist the project and validation engineers in providing Subject Matter Expert (SME) input on equipment, process and material validations. This includes testing, engineering studies, validations, change control, impact analysis, FMEA, regression testing, re- validation and development of validation methodology.

Key Responsibilities:

  • Applies Good manufacturing Principles (GMP) in all areas of responsibility
  • To support validation / qualification activities including equipment, facilities, systems, CSV and temperature controlled shippers
  • To support change control activities including equipment, facilities, systems
  • Review Facilities and Engineering processes to maintain compliance with current legislation
  • To track, trend and report on all GxP related metrics for facilities and Engineering
  • Supports practical process improvements (PPI) initiatives in order to achieve efficiency gains and process improvements throughout FCS UK Facilities
  • Other duties may be assigned to meet business needs
  • Informs management of issues identified during Facilities and Engineering activities. Recommends appropriate actions to address the issue
  • Leads in the development of test plans to ensure risk mitigation and quality requirements are met
  • Provide suggestions and improvements regarding work related processes and procedures
  • Performs risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes and materials
  • Keeps current with qualification practices

  • Assist in the writing and review of standard operating procedures (SOP)
  • Conducts all activities in a safe and efficient manner
  • Demonstrates and promotes the company vision of the 4 I’s Integrity, Intensity, Innovation and Involvement

Minimum Requirements/Qualifications:

  • Higher Education Qualification
  • Knowledge of GMP environments
  • Worked within an Quality and Facilities and Engineering environments
  • Experience in validation / qualification
  • Degree level or equivalent in relevant subjects or extensive industry experience

    Non-Negotiable Hiring Criteria:

    Experience required of:

  • Ability to work with a team providing support to other members
  • Ability to work without direct supervision / on own initiative within the remit of the role
  • High degree of accuracy, concentration, verbal and written communication


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