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?
- Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits. Provide some coaching and feedback for GMP and documentation behaviors, working with QA Managers and Operations Leads.
- Review of completed batch and / or cleaning logs, including data such as device printouts, temperature charts, test procedures, raw QC data and logbooks, to ensure that cGMP manufacturing activities have been performed and documented in accordance with approved written procedures
- Support Improvement and EBR implementation initiatives.
- Support conditional and full batch release by ensuring the completeness of the documentation package
- Review comments added to the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks), 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
- Has solid understanding of cGMP and ICH guidelines and requirements
- Bachelor, Master degree or PhD in Biology, Chemistry, Biotechnology, Life Science or other related field
- Knows the concept of deviation management and documentation
- Understands the TrackWise, SAP, LIMS, and Microsoft Office systems
- Is able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows whom to elevate to
- 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, English
We are looking forward to getting to know you and your ambitions!