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QA On The Floor Specialist

Alvotech · Reykjavik

New
Onsite Junior 🇬🇧 English
GMP GDP ALCOA CAPA SOP

Job description

About the role

Join Alvotech’s Quality Assurance team as a QA On The Floor Specialist, providing real‑time QA support to manufacturing operations in a 24/7 environment. This hands‑on position ensures compliance with GMP, GDP and ALCOA principles while contributing to the delivery of high‑quality biopharmaceutical products.

Key responsibilities

  • Act as the primary QA contact for DPM and DSM operations during rotational shifts.
  • Provide QA support for batch‑related and facility issues, including deviations and CAPAs.
  • Perform shop‑floor monitoring, review manufacturing documentation, alarm logs and failure assessments.
  • Approve area release, line clearance and other QA‑controlled activities.
  • Support media fills, cell bank issuance, AQL sampling and visual inspection activities.
  • Maintain QA documentation, support inspection readiness and contribute to SOP updates.

Required profile

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology or related field.
  • Minimum 2 years 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 manufacturing setting.

Required skills

  • GMP
  • GDP
  • ALCOA principles
  • CAPA management
  • SOP development and implementation

What we offer

  • Opportunity to work on ambitious projects that impact patients’ lives.
  • International, diverse and inclusive work culture.
  • Flexible and innovative work environment with personal growth support.
  • Company canteen, coffee house, on‑site shower facilities and wellness programs.

Questions fréquentes

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Published 1 klukkutími síðan

Expires 1 mánuður síðan

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Alvotech

Reykjavik