QA Specialist for IT Systems

Indrykket: 11.9.2020

Kvistgård

Would you like to set high standards in Quality Assurance and provide QA support in IT systems and in GxP data-generating processes? Do you want to raise the bar for IT a systems cross Bavarian Nordic? Then a position as QA Specialist with focus on IT systems in our QA team might be the position for you!

Improving health & quality of life

At Bavarian Nordic we work to develop innovative and safe vaccines to treat and prevent cancer and infectious diseases. Our aim is to improve health and quality of life for children and adults around the world. We hope that you would like to share this mission with us.

Join us on a transformational journey

With our recent acquisition of two commercial vaccines we have embarked on a transformational journey to be recognized as a company excelling in all parts of the integrated value chain; from state-of-the-art science and research and development, over manufacturing to commercialisation of products in multiple markets.

As a result, there is an increased demand for new IT GxP services which increases our need for QA support in validating IT systems and in ensuring data integrity for GxP data-generating processes across our sites in Denmark, Munich and North Carolina.

Over the next years we are e.g. planning to implement new QMS, Corporate Training, Clinical Trial Management, Regulatory and other core pharmaceutical GxP system into our IT portfolio.

Become part of an experience QA team

The team provides QA support to the Clinical, QC, Regulatory, Manufacturing and other line-of-business areas. We also support validation/qualification activities of manufacturing equipments

You will work in close collaboration with the IT Department and QA IT Compliance providing advice on QA -related matters.

You will be located in Denmark at our site in Kvistgaard

You will report to the manager for QA Support department.

As our QA Specialist for IT you will:

As QA IT Specialist you will act as QA for IT GxP system with responsibility for reviewing and approving validation documentation (VPL, URS, DS, XQPs etc.), Change Controls, Deviations and Corrective and Preventive Actions (CAPAs). and you will participate in review/approval of documentation involving qualification and validation of manufacturing equipments/IT systems.

You will:

  • Review and approve validation deliverables on behalf of Line of Business
  • Provide support and training in QA IT and Data Integrity
  • Advice the line of business on IT related topics
  • Review and approve SOPs, Change Requests, Deviations and CAPAs
  • Take active part in improvement projects in the QA department for the Pharmaceutical Quality Systems (PQS)

To succeed in this position the following experience and qualifications are required:

  • Min. 3-5 years’ experience with qualification and validation of IT systems/equipment and data generating processes within the pharmaceutical/biotech industry
  • You have a good understanding of GxP data integrity principles and data lifecycle within biotech product development and know how to communicate and apply these principles in everyday work.
  • Experience/knowledge about regulatory requirements for computerized systems
  • Experience/knowledge about implementation of IT quality management systems (QMS) such as deviations, CAPAs, change control, risk assessment and SOPs.
  • Since our cooperate language is English is require that you are fluent both verbally and in writing.

It would be beneficial if you have experience as an internal auditor or lead auditor to participate in internal audits as SME and participate in external audits within QA IT systems.

On a personal level, you are an open-minded person with a good sense of humor and an outgoing and confident attitude. You must be willing and open to make decisions and be able to stand firm towards stakeholders at all levels when required to ensure compliance, while at the same time being able to build good and personal relationships. You thrive by planning and setting an honor in implementing and performing tasks according to the plan. You are detail-oriented and a strong ambassador of a quality mind-set, but also able to apply pragmatic approaches and seeing things from a different angle when needed.

We offer

an exciting position in an international company with a unique technology and manufacturing process within vaccine/biologic production. As QA IT Specialist you will be in contact with many different departments across our three sites and you will be working in an open culture, where everybody is working in the same direction and where there is room for ideas and independent action. The company is very agile by nature and we aim for speedy implementations and for applying a pragmatic approach to reaching the right level of quality.

Caught your interest?

We are interviewing on an ongoing basis.

Further information

If you are missing some job details do not hesitate to contact QA Manager, Rúbia Gilbert Poulsen on Mobile no. +45 53 70 72 74 or by e-mail: [email protected]