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Quality System Manager for IT Systems

Do you have experience in GxP documentation practices? Do you have an eye for detail, enjoy and excel in documentation and are you able to overlook the life cycle of IT Systems? Then this position within BioPharm FP Kalundborg may be for you.

About the department

The team provides IT & Automation support for both our aseptic filling departments and our packing facility in Kalundborg. The departments employ approx. 400 employees and works in 3-shift for up to 7 days a week. Our biopharmaceutical products are characterized by complex processes supported by employees with great professionalism and commitment.

You will be part of a IT & automation team of 13 people - 7 automation supporter, 2 system manager and 5 IT specialists.

About the Position

As our new Systems Manager, you will be responsible for the management and maintenance of regulated IT Systems. You manage and overview the full life cycle from overview and control, system development, system maintenance and operation, compliance, incident and change management and finally to retirement of systems.

You will ensure optimal processes according to relevant regulatory authorities (GxP) and take responsibility for system documentation, system change management and security management.

Your role includes ensuring that the systems are compliant with relevant internal SOPs and guidelines as well as external requirements (such as 21CFR Part 11, Personal Data Protection, etc.). Furthermore, you will supervise that appropriate testing (i.e., UAT, IQ, OQ) is in place and ensuring that IT requirements are met. You will also represent IT systems in connection with audits and inspections.

Qualifications

We expect you to have a bachelors or master’s degree within science, business or similar and a minimum of 5 years of quality documentation. Furthermore, you have

  • experience in GxP documentation practices
  • experience as IT Project Manager.
  • ability to independently review and approve protocols and technical documents
  • experience in regulatory audits and inspections
  • excellent oral & written communication skills
  • Preferably, you are knowledgeable within areas such as IT frameworks (COBIT, ITIL, GAMP, 21CFR Part 11, and/or PIC/S Annex 11) and system development lifecycles including validation of computer systems, operation and maintenance as well as decommissioning of systems.


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