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QA On The Floor Specialist

Alvotech · Reykjavik

Onsite Mid 🇬🇧 English
GMP GDP ALCOA CAPA AQL sampling visual inspection

Job description

About the role

Join Alvotech’s Quality Assurance team as a QA On The Floor Specialist. You will provide real‑time QA support to manufacturing operations in a 24/7 environment, ensuring compliance with GMP, GDP and ALCOA principles while helping deliver high‑quality biopharmaceutical products.

Key responsibilities

  • Act as the primary QA contact for DPM and DSM operations during rotational shifts.
  • Support batch‑related and facility issues, including deviations and CAPAs.
  • Perform shop‑floor monitoring and enforce GMP, GDP, and ALCOA compliance.
  • Review manufacturing documentation, alarm logs, and failure assessments.
  • Approve area release, line clearance, media fills, cell bank issuance, AQL sampling and visual inspection activities.
  • Maintain QA documentation, support inspection readiness and audits.
  • Contribute to SOP updates and train new QA team members as needed.

Required profile

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology or a related field.
  • Minimum 2 years of experience in a GMP‑regulated pharmaceutical or biotechnology manufacturing environment.
  • Strong attention to detail, problem‑solving abilities and excellent communication skills.
  • Willingness to work rotational shifts in a fast‑paced production setting.
  • Proficient in written and spoken English.

Required skills

  • GMP knowledge
  • GDP knowledge
  • ALCOA principles
  • CAPA handling
  • AQL sampling
  • Visual inspection techniques

What we offer

  • Opportunity to work on ambitious projects that impact patients' lives.
  • International, diverse and inclusive work culture.
  • Flexible, innovative environment with personal growth support.
  • Company social events, on‑site canteen, coffee house and shower facilities.
  • Transportation grant, home internet support and well‑being programs for full‑time employees.

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Published 1 mánuður síðan

Expires 1 vika síðan

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Alvotech

Reykjavik