Skjalasérfræðingur í lyfjaframleiðslu - Documentation Coordinator

Alvotech leitar að Skjalasérfræðingi í lyfjaframleiðslu (Documentation Coordinator) til að ganga til liðs við öflugt teymi okkar. Þetta hlutverk hentar vel fyrir einstakling með grunn í GMP-skjölun og brennandi áhuga á stöðugum umbótum innan lyfja- eða líftæknigeirans. Viðkomandi mun gegna lykilhlutverki í að tryggja nákvæmni og samræmi framleiðsluskjala.

Helstu verkefni og ábyrgð:

• Yfirfara framleiðsluskýrslur eftir framkvæmd áður en þær eru sendar til gæðaeftirlits.
• Uppfæra núverandi framleiðsluskýrslur í samræmi við umbætur á ferlum.
• Skrifa eða endurskoða verklagsreglur (SOPs), aðalframleiðsluskýrslur (MBRs), efnalista (BOM) og önnur cGMP-skjöl.
• Fylgja eftir innleiðingu breytinga á framleiðsluferlum.
• Veita stuðning við daglega framleiðslu, í niðurstraumsferlum (DSP) og undirbúningi buffera.
  
  

Menntunar- og hæfniskröfur:

• Háskólagráða í lyfjafræði, líftækni, matvælafræði, efnafræði eða skyldum fögum er æskileg.
• 1–3 ára reynsla af vinnu í GMP-stýrðu umhverfi er æskileg.
• Öflug færni í tæknilegri skrift.
• Þekking á góðum skjölunarvenjum (GDP).
• Reynsla af lyfjaframleiðslu er kostur.
• Góð enskukunnátta.
  
  

[English]

Alvotech is seeking a detail-oriented and proactive Documentation Coordinator to join our dynamic team. This role is ideal for someone with a strong foundation in GMP documentation and a passion for continuous improvement in the pharmaceutical or biotechnology industry. You will play a key role in ensuring the accuracy and compliance of manufacturing records and supporting documentation.

Key Responsibilities:

• Responsible for post-execution MFG review of manufacturing batch records before submission to QA.
• Update existing batch records to reflect process improvements.
• Draft or revise Standard Operating Procedures (SOPs), Master Batch Records (MBRs), Bill of Materials (BOM) and other cGMP documentation within your area of expertise.
• Author change controls and be owner of change actions for process updates.
• Provide occasional support in the daily execution of manufacturing activities, particularly in DSP and buffer preparation.
  
  

Qualifications:

• Bachelor's degree in pharmaceutical sciences, biotechnology, food science, chemistry, or a related field is preferred.
• 1-3 years of experience working in a GMP-regulated environment.
• Strong technical writing skills, including the creation of controlled documents and training materials.
• Proficient in Good Documentation Practices (GDP).
• Experience in drug manufacturing is preferred.
• Proficiency in English.
  
  

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.
  
  

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.