Senior Validation Analyst
- in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With one product on the market, one candidate in registration and six candidates in the clinical pipeline, Zealand is a unique success story in Danish biotech. 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. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
Zealand is in search of a skilled and experienced computer system validation analyst for our Søborg Denmark Headquarters who will support the IT infrastructure team with compliance activities for the life-cycle management of infrastructure systems. The successful candidate will have at least 4 years of experience performing computer systems validation activities, with at least 2 years of experience with infrastructure systems.
Responsibilities include helping us to:
- Author and update technical documentation regarding IT infrastructure and related services
- Author and update policies, SOPs, and work instructions
- Lead the application and infrastructure compliance activities for assigned projects
- Manage quality issues (deviations, quality events, CAPAs) in collaboration with QA
- Ensure that quality documents remain in a compliant state (in collaboration with the system owners)
- Develop appropriate documentation for infrastructure systems
- Assist with compliance training for IT employees
- Assist with IT quality audits
The successful candidate will have the below qualifications:
- A broad understanding and hands-on experience with the relevant pharmaceutical industry standards and regulations including, 21CFRPart11, EMA Annex 11 and GAMP
- Four years of experience performing computer system validation activities
- Two years of experience working on projects involving IT infrastructure systems (on premise and cloud)
- Excellent written communication skills
- Good decision-making and time management skills
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
Please apply no later than June 11, 2021. Applications will be reviewed, and interviews scheduled on a rolling basis.
For further information, please contact Maria Nagbøl at firstname.lastname@example.org.
Applications (including CVs) will be shared with US subsidiary.
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.