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Quality Assurance Specialist

Deeside, Flintshire, CH5 2UA

ADC BIO is an innovative biotechnology Company developing new process technology to speed, simplify and significantly lower the production costs of the latest generation of anti-cancer blockbuster drugs, Antibody Drug Conjugated (ADCs).

Quality Assurance Specialist, Deeside, Flintshire

The Quality Assurance Specialist is responsible for ensuring there is adequate QA support for production activities (including batch review), oversight of material management (including the approval of materials / service providers / suppliers), pre and post approval of validation documentation and maintaining the quality management systems.

Reporting to the Quality Assurance Manager the Key Responsibilities will include:

  • Assisting in the setting up of the ADC quality management system, document management, templates and compliance activities
  • Establishing and presenting Quality Management Systems metrics to the site leadership team to promote continuous improvement
  • Support during customer and regulatory audits
  • Supporting the review of all batch related documentation
  • Supporting quality related investigations
  • Writing investigation reports and initiating/following up on corrective and preventative actions
  • Leading Quality based projects
  • Approving pre and post execution validation documents
  • Supporting material management processes to ensure materials are of the correct quality and are sourced from approved suppliers
  • Supporting batch release of clinical and commercial bulk drug substance / API against product specification files.
  • Perform self-inspection audits, and ensure any deficiencies are highlighted and then adequately mitigated
  • Ensure that all stages of Good Manufacturing Practice (GMP) are in full compliance with the required principles guidelines and any other regulatory requirements.

Skills and Qualifications required to undertake this role:

  • HND in a Biological subject area or more than 5 years working within a Quality Assurance department.
  • Minimum 12 months experience in a QA or QC role within either a Pharmaceuticals or Biopharmaceutical environment.
  • Experience using Microsoft Office suite of programs
  • Knowledge and practical experience of GMP & GLP
  • Numerical & investigative skills
  • Ability to work accurately, with attention to detail
  • Ability to prioritise and deal effectively with a varied workload
  • Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation.
  • Approachable and friendly, with the confidence to challenge results and performance when required.

We award our teams with a highly competitive remuneration package which will be discussed at interview stage but expected to be in the region of £25,000-£30,000 p.a.

Please apply with a covering letter detailing your current remuneration package.

 

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