Rýni á lotuskrám / Batch Record Reviewer (Summerjob)

Helstu verkefni og ábyrgð:

• Yfirfara lotuskrár fyrir uppstreymi, niðurstreymi, skömmtun og stuðpúða aðgerðir.
• Tryggja að skjöl séu fullbúin, nákvæm og í samræmi við GMP og innri gæðastaðla.
• Greina og skrá frávik, svo sem villur eða upplýsingar sem vantar, í samræmi við stöðluð ferli yfirferðar lotuskráa.
• Vinna náið með framleiðslu, gæða- og skjaladeildum.
• Halda nákvæmar skrár um yfirfarin gögn og framvindu.
• Veita daglegar uppfærslur og vikulegar skýrslur til verkefnastjóra.

Menntunar- og hæfniskröfur:

• Menntun: Framhaldsskólapróf.
• Reynsla: Ekki er gerð krafa um fyrri reynslu í lyfjaiðnaði.
• Hæfni: Framúrskarandi skipulags- og samskiptahæfni. Nákvæm vinnubrögð og góð kunnátta í Microsoft Office. Framúrskarandi tímastjórnun og geta til að vinna sjálfstætt.

(English)

• Review manufacturing batch records across upstream, downstream, dispensing, and buffer operations.
• Ensure records are complete, accurate, and compliant with GMP and internal quality standards.
• Identify and document discrepancies such as deviations, or missing information in accordance with standardized batch record review process.
• Collaborate with manufacturing, QA, and documentation teams to resolve issues.
• Maintain detailed logs of reviewed records and progress.
• Provide daily updates and weekly reports to the Project Lead, DS Master Planner.

Minimum education and experience required for the role:

• Education: High School Diploma
• Experience: No prior knowledge is required.
• Skills: Excellent written and verbal communication skills. Excellent attention to detail and good organizational skills. Proficient in use of a PC and common Microsoft packages such as Word and Excel. Ability to work independently and meet tight deadlines.

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.
• Excellent in-house canteen and coffee house.
• On-site shower facility.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.