Alvotech hf
Alvotech hf
Alvotech hf

QA Specialist - QA On The Floor

The QA Specialist will be responsible for ensuring the quality and compliance of our manufacturing processes. The main responsibilities will be to review and approve executed batch records and to provide QA oversight over production processes.

Helstu verkefni og ábyrgð
  • Monitor compliance with Good Manufacturing Practices (GMP) and company policies and procedures.
  • Provide QA oversight over the manufacturing processes, including cleanroom behavior and line clearance.
  • Provide guidance to production staff on deviation investigation.
  • Review batch records, logbooks, and quality documentation for accuracy and completeness.
  • Provide guidance to production staff with quality standards and practices.
  • Assist with internal and external audits as required.
  • Participate in improvement projects.
  • The position requires working on 24/7 shift pattern.
Menntunar- og hæfniskröfur
  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field (or equivalent experience).
  • Previous experience in a quality assurance role within the pharmaceutical or biotechnology industry is preferred.
  • Strong understanding of GMP, EMA, FDA regulations, and industry standards is preferred.
  • Excellent attention to detail and analytical skills.
  • Strong communication and interpersonal skills to effectively work with cross-functional teams.
  • Ability to work independently and effectively prioritize tasks in a fast-paced environment.
  • Proficiency in English, written and spoken.
Advertisement published20. March 2025
Application deadline10. April 2025
Language skills
EnglishEnglish
Required
Very good
Location
Sæmundargata 15-19 15R, 101 Reykjavík
Type of work
Professions
Job Tags