We are looking for a Senior IT Validation Manager in Product Supply Applications (PSA) who can help us enhancing and improving compliance level of our IT solutions used in ALK. Our department, PSA, is responsible for improving, upgrading and validating the global IT solutions used in Product Supply in ALK, like SAP, LIMS, EDMS, Deviation and Change Control systems etc. You are working closely together with the process owners, Global QA and Global IT to ensure the right compliance level is implemented.
Fields of responsibility
Improve and enhance IT compliance for our global IT solutions in ALK
Participate in projects, acting as validation and test lead
Take part in compliance initiatives to enhance department compliance
Liaise with Global QA when interpreting and implementing new CSV requirements and guidelines
Function as system administrator for IT test system HPQC
Maintain relevant compliance documentation
You have worked with implementing IT solutions
You have experience with IT validation (GAMP5), and Quality Assurance for IT systems (CSV)
You have excellent communication and stakeholder management skills
You can speak and write English on a professional level
You are able to work independently, can manage and coordinate tasks and medium size projects
You are proactive, service minded and team player
It is a benefit, however, not a requirement, if you have worked in the pharmaceutical industry and/or have worked with test systems like HPQC
There is a limited amount of travel
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. The job is very flexible and you have very much influence on your daily work.
For further information on the position please contact Leticia García, HR Development Consultant - email email@example.com
11 September 2018, LGJES
ALK is a global research-driven pharmaceutical company focusing on allergy prevention, diagnosis and treatment. We are the world’s leading company within allergy immunotherapy. We are constantly moving forward as we have maintained our pioneering spirit. We are large enough to offer you both challenges and good opportunities for development, but not large enough for you to disappear in the crowd.
We have experienced success and significant growth in recent years, and together with our international partners we work to expand the use of allergy immunotherapy worldwide. Therefore we need employees who both desire and are capable of influencing the company.