QA Specialist, Computerized Systems
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,300 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi’s revenues amounted to SEK 14.2 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at Sobi.com
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients, and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
Sobi offers a unique job opportunity in a dynamic and challenging environment. The position is situated in our Quality function in Stockholm, where you will be part of a team consisting of highly professional people, who work hard and have fun on the way. Sobi has embarked on a journey to become a Global Leader within Rare diseases. Digital solutions are an integral and important building block in this journey.
As QA Specialist your goal is to deliver support and advice regarding GxP regulated computerized systems. You will have a role interfacing with all parts of the Sobi organization.
Your main work tasks will be:
• QA support to line of business for computerized systems with focus on manufacturing and laboratory systems) e.g. review and approve quality related documentations such as SOP’s, specifications, validation/qualification documents, periodic reviews, change requests, CAPAs, deviations etc.
• QA Project Support involving computerized systems, data transfer, IT related topics
• Drive and take responsibility for improvement projects as applicable
• Contributing to the ongoing maintenance and optimizing the routines for computerized system e.g. updating templates, system list, VMP and follow up the periodic review of the systems.
• Contributing to the ongoing maintenance and optimizing of Sobi´s Quality System.
• Support authority inspections and partner audits from computer compliance point of view.
Lead or participation in external audits of suppliers and supplier evaluations could be included in the responsibilities depending on your background and ambition. Additionally, you will participate in various projects across the entire organization and with many different stakeholders.
Probably you hold an Engineering or a Master´s degree in IT or Life science combined with some years of experience working in a Quality role in a GxP regulated environment. Preferably you have a background working in a similar role as QA for computerized systems or from being validation/system responsible, you can also work in a quality role within IS/IT. The position is also open for applicants with a background as QA from the pharma/medical device industry and the motivation to further develop their skills within QA for computerized systems.
In-depth knowledge of regulations/guidelines for GxP regulated systems e.g. CFR Part 11, EU GMP VOLUME 4, (Annex 11), Data Integrity and GAMP is a plus. Auditor training and/or knowledge of supplier management is also a plus.
As a person you can work independently and have an ambitious mindset. You are proactive, service minded and a profound team player. Furthermore, you possess excellent communication skills, and you master English on a professional level.
This is a unique opportunity to become part of an expanding pharmaceutical company. Sobi is currently undergoing a developmental change to becoming a global company with partners all around the world. The working environment is therefore ideal for the candidate who is looking for a job with room for both personal and professional development.
For more information:
In this recruitment, Sobi is cooperating with Compass Human Resources Group. If you want more information, please contact Anders Larsson at firstname.lastname@example.org, 073-203 4691, Morgan Eilenberg at email@example.com, 073 359 05 50 or Jens Nordqvist at firstname.lastname@example.org 070-145 35 69. Interviews will be held on continuous basis, so we encourage you to apply already today.