Pia Grunewald

Prüfungen und Bewertungen im Rahmen der vom Hersteller durchzuführenden Konformitätsbewertung nach MDD und MDR. Betreuung der Hersteller und Ihrer QM-Systeme nach ISO:13485 und MDSAP.

Responsibilities: • Ensure Secondary Packaging process of pharmaceutical products and medical devices meets GMP, TGA, ISO 9001 and 13485 and client requirements • Product release with Certificate of Conformance • Release for Supply support for our clients (Pfizer, Bayer, Novartis, J&J, etc.) • Review & improvement of QM-Documentation (Batch packing records, SOPs) • Initiating of Non-conformance reports and follow up with an investigation and corrective action (CAPA)

Responsible for: -maintaining of company's quality systems, including investigations, CAPA, training - generating of quality system documentation (SOPs, deviation/investigation reports and change control) - Validation, qualification and calibration for facilities, equipment and systems - Review Inwards Goods documentation and complete Product Evaluation Forms - Review and approve Secondary Packaging batch packaging records - Review and approve Principal CoAs for required Principals

Funktionsklärung posttranskriptioneller Modifikation am Transkriptionsfaktor CREB Aufgabenfeld: E. coli Transformationen, Proteinreinigung und -quantifizierung, EMSA, Immunoblot und Enzym-Assays

Klassen R, Grunewald P, Thüring KL, Eichler C, Helm M, Schaffrath R (2015) Loss of Anticodon Wobble Uridine Modifications Affects tRNALys Function and Protein Levels in Saccharomyces cerevisiae. PLoS ONE 10(3): e0119261. doi:10.1371/journal.pone.0119261