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Qualification Validation Associate

Primary Responsibility

Adaptimmune is seeking a Quality Validation Associate within the Quality unit to primarily focus on the qualification and validation lifecycle of equipment, utilities, systems, and processes for the manufacturing of vector which is a starting material used in the manufacture of Adaptimmune T-cell drug products.  This role will also manage activities at the sites of manufacture including the management of change controls and the application of Quality risk management principles. 

 

Key Responsibilities

  1. Define Validation/Qualification deliverables including, but not limited to, requirements documents, functional and design specifications, qualification protocols (IQ/OQ/PQ), and summary reports.
  2. Develop and author installation/operational qualification protocols and equipment performance/process validation protocols.
  3. Execute Validation/Qualification Protocols, including external party supervision, identification and resolution of deviations and technical issues related to equipment, utilities, automation, and cleaning validation.
  4. Manage the re-qualification program according to Adaptimmune policies
  5. Perform periodic review of equipment and systems according to Adaptimmune policies
  6. Manage the execution of aseptic process validation activities including authoring protocols, evaluating process and assay data, investigating protocol deviations and acceptance criteria failures, and compiling final summary reports. 
  7. Coordinate validation projects with cross-functional teams including quality assurance, manufacturing operations, process development, quality control, etc.
  8. Act as quality oversight for calibration and maintenance activities
  9. Assist in the development and maintenance of various systems within the Quality unit including preparation of SOPs, documentation control support and implementation and management of the change control system.  Punctual support to the quality unit depending on workload (material release, document issuing …)
  10. Assist in risk assessments using a variety of tools, e.g. FMEA and HACCP.
  11. Participate in efforts to identify opportunities for and to implement continuous improvement of practices related to validation.

 

Qualifications & Experience

Required

  • BSc or MSc degree in life science or engineering 
  • Previous experience in validation, technical operations, or quality assurance.within a Pharmaceutical/Biotech company
  • Must have experience in the writing of technical documents
  • Must have experience of creation of experimental design and be motivated to do hands on testing of equipment
  • Must have knowledge of cGMP, GDP and best industry practices.
  • Must have good communication skills

Desirable

  • Experience in validations, including but not limited to product, process, equipment, test methods, DOE, cleaning and software validations
  • Previous experience in a GMP or GLP environment
  • Previous experience in pharmaceutical/biotech manufacturing
  • Knowledge of Calibration and Maintenance

 

Skills & Compentencies

Required

  • Good written and verbal communication skills
  • Must be rigorous, organised and have attention to details
  • Must be able to work well on cross-functional teams, as well as perform independently.
  • Must be self-motivated and have good interpersonal skills

Desirable

  • Able to manage multiple priorities
  • Strong organizational and project planning skills.

 

Other Requirements

Domestic travel required (up to 5%)

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