Quality & Compliance Consultants - 6 Months Contract

You will be responsible for ensuring that the IT part of our production equipment is in compliance.

You manage and overview the full life cycle from system development, system maintenance & operation, and compliance.

You will ensure optimal processes according to relevant regulatory authorities (GxP) and take responsibility for documentation for the IT part of automated systems (Computerized Equipment) and security management for the system.

Your role includes ensuring that the systems are compliant with relevant internal SOPs and guidelines as well as external requirements. Furthermore, you will supervise that appropriate testing is in place ensuring that IT requirements are met. You will also represent IT part of the systems in connection with audits and inspections.

You will create/update ITRA's URR's URS', ITPSE's, Disaster Recovery Plans and other compliance documents used for PS AM in the role as IT responisble (Computerized Equipment) resp. IT System Manager (IT Systems)

You will be based at Nybrovej 80, 2820 Gentofte

Skill/Experience/Education:

We expect you to have a bachelor’s or master’s degree within science, engineering and a minimum of 3 years of experience with quality documentation.

Furthermore, you have excellent oral & written communication skills in Danish

Excellent oral & written communication skills in English

Ability to independently make technical documents

Preferably, you are knowledgeable within areas such as IT frameworks, system development lifecycles and operation and maintenance of automated systems.

Data Privacy Requirements

Requirements for DDIT PS AM

Required skills

Quality

Compliance

Languages

English