Peter Back Email & Phone Number

Hellerup, Capital Region, Denmark

Due to a medical condition I'm only able to work part-time.QA Development, IMP-team (Investigational Medicinal Products):- Review and approval of packaging related documentation- Perform batch record review including evaluation if the batch is fit-for-purpose- Handling of temperature excursions- act as support to the Clinical Trail Support teams regarding IMP release- responsible for the QA oversight of outsourced packaging and labelling activities at CMOs- ensure continuous good relations and alignment with CMOs - maintain updated with insights into processes and systems. at CMOs- initial knowledge in deviation handling- initial knowledge in performing external audits at CMOs

Måløv, Capital Region, Denmark

Bulk, Cleaning, EM and Review: - Production review of tabletting documentation

Måløv, Capital Region, Denmark

Pack Process Support: - Production review of packaging documentation

Copenhagen, Capital Region, Denmark

Quality Control - Release - performance of HPLC and IC analysis- review of analysis documentation

Kaiseraugst, Switzerland

Quality Control - Cleaning Validation- performance of HPLC and LC-MS analysis- review of equipment qualification documentation- method development and validation

Wehr, Germany

Quality Control - Release - performance of HPLC and dissolution analysis et al.- review of analysis documentation

Måløv, Capital Region, Denmark

Research & Development - Method development and analytical support- performance of HPLC and dissolution analysis et al.- method development and validation