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Open nowPosted 4 days ago

Senior Specialist, Quality Control

alvotech15 open roles

Where
Reykjavik Headquarters
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Your applicationOpen nowSenior Specialist, Quality Controlalvotech · Reykjavik Headquarters

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The clock on this job

Early applications get read.

13.6% of postings close within 7 days. Measured by our own scanner across the market. alvotech postings stay open a median of 13 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.7%3 days
  3. 13.6%7 days
  4. 21.9%14 days
  5. 36.9%30 days
  6. 59.0%60 days
This job: posted 4 days ago

alvotech median: 13 days open

The posting

The Quality Control department at Alvotech is looking for a dedicated and quality-minded senior specialist, with extensive experience in Analytical method technology transfers, CAPA management, Health Authority response, analytical investigations and scientific oversight.

Scope and responsibility:

  • Lead Analytical technology transfer activities between Alvotech and CMOs, ensuring successful method implementation and Lifecycle management of analytical methods.
  • Act as the analytical subject matter expert for product testing methods, including chromatography, electrophoresis, compendial, and biochemical techniques.
  • Coordinate transfer activities, troubleshoot technical challenges, and drive timely resolution of method-related issues.
  • Author and Review transfer protocols, reports, validation
  • undefined
  • Author, review and approve CAPAs, change control, Document change controls, deviation investigation action and associated quality documentation.
  • Lead and support investigations related to analytical quality events, including invalid assays, OOS, OOT, and OOE results.
  • Lead the preparation of responses, scientific justifications for regulatory and Health Authority inquiries.
  • Collaborate with ARD, Regulatory Affairs, Manufacturing, MSAT, and Quality Assurance teams to support product lifecycle management.
  • Drive continuous improvement initiatives to enhance laboratory compliance, efficiency, and effectiveness.
  • Ensure activities comply with cGMP requirements, internal procedures, and regulatory expectations.
  • Perform training of other scientists in Analytical methods and related activities.
  • Creates and updates documents for analytical methods

Job requirements:

  • Bachelor’s or master’s degree in technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field)
  • 5-10 years of experience in Pharmaceutical or Biopharmaceutical industry.
  • Proven experience in analytical method technology transfer and product lifecycle management.
  • Strong experience in managing CAPAs, Change Controls, Deviations, and complex analytical investigations.
  • Experience supporting regulatory submissions and responding to Health Authority queries.
  • Expert knowledge within field of expertise such as methods, techniques as well as relevant procedural/process knowledge
  • Open to flexible working hours.
  • Excellent written and verbal communication skills.

What we offer:

  • An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
  • The chance to be a part of a global and fast-growing company.
  • An international work culture that encourages diversity, collaboration and inclusion.
  • Positive, flexible, and innovative work environment.
  • Support for personal growth and internal career development.
  • Company social events and milestone celebrations.
  • Excellent in-house canteen and coffee house.
  • Exercise and wellbeing support for full-time employees.
  • On-site shower facility.
  • Transportation grant towards eco-friendly modes of travel for full-time employees.
  • Internet at home for full-time employees.
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