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Batch Record Reviewer

  • Alvotech
  • Reykjavík, Iceland
  • ISK 6,000,000 – ISK 8,000,000

Hefur þú gott auga fyrir smáatriðum og áhuga á gæðamálum í lyfja- og líftækniiðnaði? Við erum að leita að metnaðarfullum Batch Record Reviewer til að tryggja að framleiðsla okkar uppfylli strangar reglugerðarkröfur og hæstu gæðastaðla.

(English)

Are you detail-oriented and passionate about quality assurance in the pharmaceutical or biotech industry? We are seeking a dedicated Batch Record Reviewer to ensure compliance with regulatory standards and maintain the highest quality in our production processes.

Scope & Responsibilities:

  • Review and approve batch records for accuracy and completeness.
  • Ensure compliance with cGMP regulations and internal SOPs.
  • Collaborate with cross-functional teams to resolve discrepancies.
  • Participate in audits and inspections as needed.

Qualifications and skills:

  • Bachelor’s degree in a scientific discipline or equivalent experience.
  • Experience in batch record review or quality assurance in a regulated environment is a plus.
  • Strong attention to detail and analytical skills.
  • Excellent communication and teamwork abilities.

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.

Skills

  • cGMP
  • Batch Record Review
  • Quality Assurance
  • Regulatory Compliance
  • Attention to Detail
  • Analytical Skills
  • Cross-functional Collaboration

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