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GxP Training Manager - Quality and Compliance

Date: 27-Apr-2022

Location: Oxford, GB

Company: oxfordbiom

Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

 

Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines.  The team are accountable for internal and external audits, quality compliance and control.

 

We are currently recruiting for a GXP Training Manager to champion, develop and managing activities involving GxP Training and Compliance, as well as the development and implementation of policies and Standard Operating Procedures (SOPS) to ensure Oxford Biomedica’s Training program is compliant with relevant regulatory and quality requirements and guidelines.

 

Your responsibilities in this role would be:

  • Responsible for defining company policy and developing company GxP Training strategies
  • Developing, continuously improving, and implementing procedures, training materials and ways of working
  • Promoting the understanding of and compliance to GxP Training related regulations
  • Responsible for ensuring that anyone performing GxP tasks has adequate and consistent training to meet compliance requirements
  • Improving Quality and GxP Training effectiveness
  • Manage and deliver the process for scheduling, delivery and recording of all training within the GxP environments
  • Working directly with Department owners and Managers to establish GxP training plans and curricula.
  • Routinely identifying, assessing and managing risks, recommending mitigation strategies to quality management.
  • Leading and/or supporting investigations related to training events
  • Review & approve deviations, change proposal or other quality records with training impact
  • Auditing (or supporting audits) of site training processes and suppliers.
  • Act as GxP Training SME with external regulators, clients and company management

 

To be successful in this role, you will have the following skills and experience:

  • Bachelor’s Degree in a scientific discipline
  • A strong working knowledge of GCP, GLP and ICH requirements
  • Previous experience within Advance Therapeutic Medicinal Products (ATMPs)
  • Proven experience in the Pharmaceutical industry within QA
  • Strong verbal and written communication skills
  • Excellent organization and multi-tasking skills
  • Ability to think strategically in order to improve current processes
  • Ability to work independently and prioritise with minimal supervision
  • Ability to work effectively across a matrix organisation

 

Do you want to feel inspired every day?  We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

 

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