Senior Validation Analyst, Zealand Pharma / 1733
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. They 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). See more at www.zealandpharma.com
Zealand´s employees are fundamental to their success, and they continue to be able to attract and retain people with vast experience and talent. They have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
To support the expanding portfolio and the continued global growth of Zealand, Best Talent is now on behalf of Zealand in search of a skilled and experienced Senior Computer Validation Analyst for the Headquarter in Søborg.
You will be part of a dynamic team with engaged and dedicated people in a stimulating international environment, where you will be able to put your mark and have high influence on the working processes in the IT area. The communication will be open, honest, and direct and one of the core values in the team is
“you are never better, than your last feedback”.
Senior Validation Analyst
Engaged, pragmatic & development-oriented
- Biotech company with innovative peptide-based medicines
- Making a difference in people’s lives with metabolic & gastrointestinal diseases
- You are skilled in infrastructure systems & computer system validation
We are in search of a skilled and experienced Senior Validation Analyst, who will support the IT team with compliance activities for the life-cycle management of infrastructure systems.
You will be working in an international environment and have interfaces with many different disciplines working closely together with QA and other sites around the US. We are looking for a strong specialist, who can actively drive the following responsibilities:
- Author and update of 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
At Zealand they understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary, and cross-cultural working environment characterized by strong teamwork, room for individual performance and development, informality and respect, high work-ethics, engagement, and fun.
Zealand is a growing organization, and you will be encouraged and welcomed to bring forth new ideas, discuss concerns and share feed-back with colleagues and management. You will report to the IT Compliance Manager.
The ideal candidate holds a degree in Life Science, with at least 5 years of experience performing computer systems validating activities and working with different IT-platforms.
The successful candidate will have the following profile:
- A broad understanding and hands-on experience with the pharmaceutical industry standards and regulations including 21CFR Part 11, EMA Annex 11 and GAMP
- Experience working on projects involving IT infrastructure systems (on premise and cloud)
- Excellent written communication skills
You must have a proactive mindset and a desire to continuously develop and find innovative solutions to IT challenges. In addition, you are well-organized, and have the ability to plan, execute and meet deadlines. You are a pragmatic person and see opportunities instead of difficulties.
You are motivated by having a high impact position and understand how to apply your cultural awareness to inspire trust and respect among your international colleagues. As an open-minded dedicated and flexible person, you utilise your high level of energy and can-do attitude to proactively handle the various tasks at hand.
Strong communication skills are essential in this role, which interacts with other disciplines. You have the ability to work independently, and as part of a project, and you are keen on working in a multi-cultural environment. You are of course proficient in English, both written and verbal.
Best Talent is responsible for the recruitment for this position at Zealand and review your application on a confidential basis. Forward your application including your CV attention ”1733/Sr.Validation Analyst” by way of e-mail to firstname.lastname@example.org You can read more about Best Talent at www.besttalent.dk.