Alvotech is looking for a specialist to work on computer systems validations.
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:
- Manage validation projects of GMP computer systems and qualification of IT infrastructure with GMP impact.
- Responsible for validation deliverables and support the business goal for go-live with their computer system.
- Ensure continuous compliant validation status of computer systems and IT Infrastructure.
- Create and facilitates validation documents; including plans, specs, protocols, etc.
- Facilitates and performs periodic reviews.
- Advice on quality matters, and assistance for closing compliance gaps found in audits and inspections.
- Participate in a dialog with infrastructure administrators, application administrators and system owners or relevant stakeholders to secure and maintain validated computer systems and qualified IT infrastructure.
Minimum of a BSc in a relevant scientific discipline and direct industry experience, or 3 years’ experience in Pharmaceutical or Bio-pharmaceutical sector.
Experience and Skills:
- Knowledge of GMP standards.
- Knowledge of and experience with FDA and EMA regulatory requirements in GMP, 21 CFR Part 11 and EU GMP Annex 11, required.
- Knowledge of GAMP 5 and computer system validation required.
- 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:
- Alvotech is a multinational workplace with employees from all over the world, benefiting from the diversity and the great talent that all of the employees bring into their work.
- Alvotech is a dynamic company that is expanding and growing at a fast pace which involves a lot of growth opportunities for employees within the company.
- Alvotech‘s working environment is friendly and full of energy, employees maintain their good energy by enjoying gourmet bistro at lunchtime; a professional coffee bar and a fully equipped gym with classes taught daily.
- Alvotech has an active social life that is highly appreciated by the employees, managed by a group of employees that plan all kinds of fun events.
- Alvotech is committed to being at the cutting edge of technology by using some of the best equipment and processes in the industry. With the core mission of improving people´s lives by providing live changing treatments to patients worldwide, the purpose of all Alvotech employee´s work is clear.
- Alvotech already has a powerful group of people that are experts in their fields and we are excited to have more great colleagues to join us.
See more at https://storf.alvotech.is/