Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence the U.S. as well.
Our QA department is looking for a new QA IT colleague.
The candidate will be part of a great team of three in the department; QA Computerized Systems which support the business with IT QA resources and GxP computerized system implementation and operation.
You will be a member of QA IT Unit who sets the frames for how we validate and qualify our systems and infrastructure in Zealand Pharma. QA IT keeps an oversight of our internal GxP systems and infrastructure as well as our CROs implementation and use of critical GxP systems
.
Job Profile
Responsibilities include:
- Partner with Zealand businesses to ensure compliant GxP computerized system implementation and operation
- Ensure initial evaluation and continued oversight of vendors and their subcontractors’ critical GxP IT systems
- Partner with Zealand IT department to develop, improve and approve qualification of Zealand GxP infrastructure
- Support inspection readiness activities within IT and data integrity
- Handle and develop the quality system on GxP systems in Zealand Pharma
Candidate Profile
The successful candidate will have most or all of the below qualifications:
Experience
- 3+ years in experience with GxP IT systems and infrastructure in the pharmaceutical/biotech industry
- 3+ years in experience with GxP IT systems and infrastructure in the pharmaceutical/biotech industry
- Practical experience with FDA 21CFRpart 11, EU Annex 11, and GAMP 5.
- Strong practical knowledge of GxP and authority inspections.
- Strong oral and written communication skills in English
Personal qualifications
- You are a team player, who is proactive, takes ownership of tasks and can easily prioritize critical tasks.
- You pay attention to details and thrive working in projects.
- Ability to work in a dynamic environment and motivation for taking on new challenges
- Pragmatic and yet with a compliant quality mindset
- High standards for ethics and integrity
- High degree of structural skills and ability to transform them to practical solutions
- Energy and drive for team results, consistent high-performer
- Ability to work effectively in a fast-paced environment
- Enjoy to be in a great team and achieve things together
What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit
www.zealandpharma.com.
Application
Please apply no later than August 31st, 2022. Interviews will be done on a rolling basis.
For further information, please contact Associate Director, Head of Computerized Systems, QA Pernelle Quist at PQU@zealandpharma.com
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.