Alvotech hf
Alvotech hf
Alvotech hf

QA specialist

We are seeking a highly motivated and experienced QA Specialist to join our Quality Assurance team. The successful candidate will be Independent in assignments. Routinely leads projects and/or supervises small or medium-sized teams of technicians or admin. Performs both routine tasks within procedures and processes and non-routine tasks. Take part in large projects. Challenges and decisions are discussed, made and solved in cooperation with supervisor/other employees. Can make adjustments/changes to procedures, processes, and projects.

Helstu verkefni og ábyrgð
  • Working as a QA contact person with DSM and DPM.
  • Provide general QA expertise and support for DSM and DPM.
  • Provide QA expertise during the investigations of Deviations, Risk Assessments, OOS; and QA approve these and their related CAPAs.
  • Support and approve Change Control records.
  • Participate in CAPAs resolution of inspection findings.
  • QA review and approval of batch records and associated documents from DSM and DPM.
  • QA review and approval of product specifications and master batch records.
  • QA review and approval of records and reports related to area of responsibility.
  • QA review and approval of Standard Operating Procedures (SOPs) related to area of responsibility.
  • Contribute to the preparation of inspections as per defined and agreed role.
  • Train new members of the QA Operations (DSM and DPM) team and other employees as needed.
  • Participate in continuous improvement of the Quality Management System.
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.
  • Strong communication and interpersonal skills to effectively work with cross-functional teams.
  • The ability to work independently and effectively prioritize tasks in a fast-paced environment.
  • Proficiency in English, written and spoken.
Advertisement published16. April 2025
Application deadline7. May 2025
Language skills
EnglishEnglish
Required
Very good
Location
Sæmundargata 15-19 15R, 101 Reykjavík
Type of work
Professions
Job Tags