Manufacturing eSystems Specialist at Alvotech · Reykjavik

Manufacturing eSystems Specialist

Scope and Responsibilities:

• Manufacturing Administration: Manage electronic execution systems, including but not limited to:
  • Master Control Electronic Batch Records for (DS): USP, DSP, and Dispensing
  • SAP for manufacturing
  • eLogbooks in manufacturing.
• Oversight Duties : Oversee the creation, upkeep, and review of:
  • Electronic Batch Records for USP, DSP, and Dispensing
  • If required, SAP Master Recipes, Process orders, Reservations and Consumption process − Electronic Logbooks for USP, DSP, and Dispensing
  • Veeva documentation required for eBR and eSystems (CC, CAPA, DEV)

Oversight duties are being performed in collaboration with Subject Matter Expert from each manufacturing function and with collaboration with Quality Assurance.

• Training: Provide training to company employees in the use of eSystems where required and relevant to eSystems requirements.
• Scalability: Adapt to the administration of new eSystems as they are introduced into manufacturing.
• Innovative Improvements:
  • Initiate and implement innovative improvements for the systems in use.
  • Act as a Subject Matter Expert (SME) for validation and qualification documentation, and collaborate cross-functionally with IT to test and implement innovative solutions, enhance operational efficiency, and ensure compliance with applicable quality standards.
• Independently implement and deliver assigned projects, ensuring timely completion and compliance with quality standards.
• Contribute to team objectives through effective collaboration, knowledge sharing, and teamwork.

Job requirements:

• BSc or Diploma in a Technical Discipline (e.g., pharmacy, biotechnology, biochemistry, engineering, or a related field).
• Preferably 3-5 years of experience in pharmaceutical industry or other related industries.
• Team player with strong organizational skills.
• Excellent written and verbal communication skills.
• Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel.
• Excellent command of English language, both written and verbal.

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.