Are you passionate about technology and like to take on complex technical challenges? Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?
· Review of the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks)
· Support batch release by ensuring the completeness of the documentation package
· Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
· Support the initiation of deviations and investigations for Batch Record review related observations
· Collect and evaluate on a regular basis KPI data
· Write and revise SOPs in his/her area of expertise
· Bachelor degree or equivalent
· Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
· Ability to identify non-compliance and gaps from quality standards
· Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
· German native/very proficient and English good command are required
We are looking forward to getting to know you and your ambitions!