Computerised System Specialist, GMP

1 week ago

Stockholm, Stockholm, Sweden Anocca Full time

Join Our Team as a Computerised System Specialist

We are currently seeking an experienced and motivated Computerised System Specialist to join our dynamic team. As a pivotal part of our operations, the Computerised System Specialist will play a crucial role in ensuring GMP compliance for our computerised systems, both within production facilities and in QC laboratories. If you have a passion for technology, software, IT infrastructure and a keen eye for detail, we encourage you to apply.

About the Role

As a Computerised System Specialist, you will be the link between operators using various computerised systems and IT, with the main focus to obtain and maintain GMP compliance for the systems and software used in the manufacturing of ATMP products for clinical trials. The role at Anocca is suited to experienced and motivated professionals with a drive to lead and execute by action. Experience in computerised system validation as well as in electronic batch management systems would be a significant asset.

You should have high-quality relevant experience, excellent English communication skills, curiosity in various software and system applications, and be securely anchored in GMP regulations. You must be capable of working as part of a team but should also demonstrate initiative to drive projects forward.

What We're Looking For:
  • Significant and relevant experience in computerised system validation
  • Significant experience in batch management system administration
  • Significant experience from working with computerised system administration in the pharmaceutical industry under GMP regulations
  • Great knowledge about data integrity ALCOA+ principles
  • Experience in general system maintenance, including user privileges, record keeping, application and data back-up etc
  • It is beneficial to have a grasp of ATMP manufacturing operations
  • It is beneficial if you have previous experience with systems like Brookhaven FMS5, Hanwell EMS, Chronicle, Unicorn, BD FACSsuite, SMARTcontrol/MARS
  • Fluent written and spoken English
Why Join Us?

Our company is at the forefront of technological innovation, striving to make a difference in the industry. We offer a dynamic working environment where talent and ambition are recognized and rewarded. Join us, and be part of a team that values growth, collaboration, and the pursuit of excellence.

We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional development.
  • A collaborative and supportive work culture.
  • State-of-the-art facilities and resources.
How to Apply:

If this Computerised System Specialist position resonates with you, we would love to hear from you. Submit your application, including your CV and a cover letter, through our careers portal. Join us in making a difference, apply now


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