Medical Device Engineers – Side job/Freelance

Pharma IT is searching for Medical Device Engineers to support development/assessment of Medical Device products within all the different types of Medical Devices as defined in EU REGULATION 2017/2185 – Link Our aim is to build a competence database of Medical Device Engineers, who can support our customers within development/test/assessment of Medical Devices on a freelance …

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Steen Lindebjerg passes CIPP/E

Steen Lindebjerg, one of our Data Protection and GDPR specialists, just passed his CIPP/E exam this week.  CIPP is Certified Information Privacy Professional Europe and it encompasses pan-European and national data protection laws, key privacy terminology and practical concepts concerning the protection of personal data and trans-border data flows.  Passing the exam shows that Steen …

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Pharma IT is searching for freelance consultants

Pharma IT is searching for freelance consultants with experience from the Pharmaceutical, Biotech and Medical Device industry. Pharma IT is experiencing an increase in customer requests and we need additional help to fulfill our customers needs. If you are a freelancer with knowledge and experience from the Pharmaceutical sector, please feel free to register your …

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Cost effective turn-key solution for becoming compliant with MDR and IVDR by May 2020/2022

Small and medium size medical device companies By May 2020 medical devices companies will have to comply with the new EU Medical Device Regulation (MDR). For Vitro Medical Devices (IVMD) the date is May 2022. The regulation holds several new and/or increased requirements that must be adhered to: Implementation of a Quality Management System, with …

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Data Integrity

Data Integrity is an increasingly important topic in the Pharmaceutical Sector. Partly because it is on the agenda with the regulatory bodies and a topic for inspections, resulting in a significant number of observations, FDA Warning Letters and EU Non-Compliance Reports.   Specializing in Pharma and IT we have been assisting preparing for a Pre-Approval …

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Pharma IT is welcoming three experienced consultants

Pharma IT is welcoming three experienced consultants

With this addition our team of experienced people and young talents is growing and making us stronger within quality, compliance and more knowledgeable within pharma business processes. Also these three profiles all have had experience working with – and validating SAP systems.

The three new consultants in Pharma IT are:

 

Ilhem Sahnoun Østergaard

Senior Consultant with over eighteen years’ experience in the Pharmaceuticals Industry. Validation lead for several GxP projects. Experience with planning, requirements (documentation in particular), test design, conducting tests, reporting and collaborating with IT departments and external vendors

 

Tine Falk

More than 15 years of experience with implementation projects and system operation. She is highly specialized in GxP. She has performed in roles such as Compliance Consultant and Test Manager.

Tine also have 5 years of experience as SAP System Manager in a highly complex environment.

 

Nini Redøhl

More than 10 years of experience with IT compliance, Quality Management and System Administration within the Pharmaceutical industry. Working as Validation Track Lead in IT implementation and upgrade projects.

Experience primarily with Corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel

 

With this latest addition to the team we believe we have one of the absolutely strongest Compliance and Validation teams within Danish Pharma. See our team here – and don’t hesitate to contact us.