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Senior IT QA Academic - Denmark  

Lundbeck (company)


Posted on : 01 May 2017

Project Description

  • Do the words DATA INTEGRITY, GAMP 5, RISK MANAGEMENT and COMPUTER VALIDATION ring a bell? Do you have experience working with these topics in the pharmaceutical industry? Are you flexible and open minded and looking for new challenges and opportunities?
  • If yes, we are looking for a colleague, with a strong background in IT quality, for a new position in our team. 
  • You will join the 3 colleagues in the Corporate Quality Assurance IT department.
  •  The department is organized in the Quality Global Supply Chain at our company , which consists of more than 100 dedicated colleagues.
  • We offer the chance to work with talented and skilled colleagues, and the opportunity to develop your professional and personal skills.
  • The mission of Corporate QA IT is to ensure the quality and compliance for all GXP systems in the entire company  group including subsidiaries.
    • We own and maintain the company  frameworks for computer validation and data integrity
    • We ensure the level of quality for individual validations
    • We audit IT vendors and service providers, validated IT systems and Corporate IT at our company.
    • We are involved directly in changes for validated systems and Corporate IT

Your job and key responsibilities 
  •  In close cooperation with the team, the successful candidate will be tasked with solving a broad suite of tasks that range across the responsibilities of the department.    
  • You will work with a variety of stakeholders, system owners and business areas within the company in order to help ensure the quality and compliance of IT systems in the entire company.
  • You will help maintain the quality system of the company and you have the chance to influence it significantly. 
  • You will help ensure that computer systems are validated in a way that is both compliant and value adding. 
  • You will be involved in change management to ensure that the validated state of computer systems is upheld through the lifetime of the system.

Our preferred candidate has the following personal and professional qualifications:
  • Has a proven track record in working with IT Quality and compliance in the pharmaceutical industry
  • Is structured and responsible with respect for deadlines
  • Has the power to push for change and make decisions when needed while at the same time being an excellent team player
  • Has the capacity to prioritize assignments, identify opportunities for improvement, take initiatives and see them through
  • Holds a Master’s degree in a relevant discipline (or other applicable education)
  • Ability to Speak, read and write English on a high professional level is required
  • Proficiency in a Nordic language and the ability to understand Danish is an advantage
  • You have a background in QA in the pharmaceutical industry, working with validation of computer systems for at least 5 years
  • You have clear understanding of the various pharmaceutical quality systems and optimally you have been working with more than one of them.

We offer
We are an internationally oriented group that offers excellent laboratory facilities, an open atmosphere, highly qualified colleagues and a warm social climate.

About us:
  • Our company  is a global pharmaceutical company specialized in psychiatric and neurological disorders. 
  • For more than 70 years, we have been at the forefront of research within neuroscience. 
  • Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease. 
  • An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences.
  • Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders – we call this Progress in Mind. 
  • Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. 
  • Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries.