Alvotech hf Sæmundargata 15-19, 101 Reykjavík
Alvotech is looking for a specialist to work on computer systems.
Key Responsibilities and Work assignments
Be able to work in accordance with GMP practices, conducting all activities in a compliant manner. Willing to take on additional activities with little to no supervision. Contribute to continuous improvement of procedures and processes at Alvotech.
Responsible for performing the following;
Minimum of a BSc in computer science and direct industry experience, or 3 years’ experience in Pharmaceutical or Bio-pharmaceutical sector.
Experience and Skills
Minimum five years experience in system/application administration.
A solid understanding of IT infrastructure and application management.
Knowledge of GMP standards and good documentation practices.
Knowledge of GAMP 5 and computer system validation benefit.
Knowledge of and experience with FDA and EMA regulatory requirements in GMP, 21 CFR Part 11 and EU GMP Annex 11, benefit.
Knowledge of key IT quality management processes, e.g. software engineering, quality management, change management, configuration management, risk assessment, test and auditing within the Pharmaceutical or Medical Device Industry required.
Good communication skills and fluent English language in speaking and writing.
It is requested that the applicant is able to start work at the earliest possible convenience. All applications will be handled as confidential.
The deadline for applications is 14th June 2019 and will be answered once a decision has been made.
For further information regarding the position please send us an email at email@example.com.
Alvotech is a privately owned, fully integrated specialty biopharmaceutical company focused exclusively on the development and manufacturing of high-quality biosimilar products, all along the value chain from cell line development to commercial manufacturing.
The company is well on its way to becoming a global leader in the biosimilar space and is helmed by an outstanding management team and prestigious group of shareholders.
Alvotech prides itself on attracting highly experienced industry talent, drawn by its purpose-driven culture. With its strong emphasis on excellence and commitment to improving the lives of patients by making biologics more accessible around the globe, Alvotech strives to promote a culture of diversity and inclusion.
What we can offer:
See more at https://storf.alvotech.is/