QA Professional

1 miesiąc temu

Gdańsk, Polska LEO Pharma Pełny etat
Your role

 

In the R&D Quality team you will be working closely together with internal and external stakeholders to ensure LEO Pharma’s processes and systems are maintained and in line with regulatory expectations and industry best practice.
 
In relation to Global Regulatory Affairs, Global Medical Affairs and Global Safety

  • Quality approval of QMS documentation such as deviations, change controls and CAPAs
  • Contributor to Quality Management Review and trending
  • Support the continuous improvement on the Quality Management Systems and processes
  • Provide training, quality expertise and advice to stakeholders
  • Coordinate, co-host and follow-up on audits and inspections
  • Contribute and lead improvement projects

 
You will be an important contributor and driver of improvement activities within the safety and QA Quality areas.
You will work across the global organization and be in contact with colleagues in various departments and functions.
 
Your qualifications


To succeed in this role, we imagine that you have the following qualifications:
 

  • Relevant life science master’s degree
  • Solid pharmacovigilance and regulatory affairs knowledge and ability to apply this knowledge and solve problems in new areas in a risk-based manner
  • Familiar with GVP quality regulations
  • Fluency in English 

 
Preferred but not essential Qualifications:

 

  • Quality Assurance experience
  • Audit and inspection experience
  • Good Laboratory Practice (GLP) experience
  • Good Clinical Practice (GCP) experience

 
The ideal candidate works willingly and effectively with others in and across the organization to accomplish team goals. Furthermore, knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making is beneficial. Last, but not least you show great interpersonal and networking skills, and you value people’s opinions and encourage knowledge sharing.
 
You are a “self-starting” and highly structured person that can plan your own work and get things finished on time. Working cross-organizational takes strong communication and collaboration skills – in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions.
 
You possess the ability to define risk as it relates to specific non-conformances or trends and work with colleagues to mitigate identified risks.
 
By joining the team, you will have a unique opportunity for personal and professional development and to contribute to business-critical processes. Furthermore, you will have the possibility to have an impact on the department and influence on your own job.
 
Your new team


R&D Quality is a part of the Corporate Quality area in the Global Quality organization. In R&D Quality we are the responsible Quality function covering R&D activities across the entire LEO Pharma organization in RA, Safety, CMC, Clinical Operation, Medical Device and DDC and IMP QP release within all GxP areas incl. GCP.
 
You will join 14 enthusiastic and very experienced colleagues – we are auditors, qualified persons and specialists within the field of responsibility of R&D Quality. Quality in a business-related context is part of our common DNA and we strive to challenge and drive the Quality path forward to ensure the success of LEO Pharma. In our team, we discuss and investigate to find the best solutions for our patients, for LEO Pharma and for our stakeholders. Strong characteristics of our department are that we always try to see processes from end to end and that we are open to input. You will join a team of dedicated and energetic specialists in an informal work environment where everyone is heard. Our aspirations are to excel at executing, being professional and ambitious, while never forgetting to have fun We are driven by integrity and compliance.
 

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