GxP ALM & Automation Specialist
ALK
Get a reply from this employer
Your resume and cover letter, tailored to exactly what they’re hiring for.
Job summary
ALK is seeking a GxP System Specialist to own the OpenText ALM and GxP automation. You will ensure regulatory compliance, drive improvements, and support validation activities across global sites.
Key tools include OpenText ALM, OpenText UFT, and Veeva Vault; you will document processes, refine SOPs, and collaborate with teams in Hørsholm, Madrid, and Krakow, with travel up to 10 days per year.
Qualifications
- Bachelor’s or Master’s degree in computer science, engineering, or a related field.
- 3+ years in pharmaceutical or other GxP-regulated industries.
- 3+ years of hands‑on experience with CSV and GxP compliance requirements.
- Solid, hands‑on experience with ALM (Application Lifecycle Management).
- Experience with Veeva Vault QualityDocs and Veeva Vault RIM is an advantage.
Responsibilities
- Own and continuously improve ALK's Application Lifecycle Management system (OpenText ALM) and GxP automation.
- Support computer system validation (CSV) activities for ALK’s automation and test-automation solutions (OpenText UFT) within GxP scope.
- Drive the creation and maintenance of QMS SOPs and Work Instructions for OpenText ALM and OpenText UFT.
- Proactively identify and manage improvement opportunities across Global IT systems.
- Coordinate GxP compliance activities across ALK's Veeva Vault portfolio.
Skills
Education
Tools
Job description
ALK is seeking a GxP System Specialist to own the OpenText ALM and GxP automation. You will ensure regulatory compliance, drive improvements, and support validation activities across global sites.
Key tools include OpenText ALM, OpenText UFT, and Veeva Vault; you will document processes, refine SOPs, and collaborate with teams in Hørsholm, Madrid, and Krakow, with travel up to 10 days per year.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
