en
GMP Documentation
anonym
(Pharma und Medizintechnik, < 10 Mitarbeiter)
Schlagwörter
Skills
Medizintechnik / Pharma Projekt Management (Europa, USA, Japan), Qualitätsmanagement, GMP Guidelines und Gesetze z.B.: AMWHV, EU-GMP Leitfaden, ICH Guidelines und FDA/USA 21 CFR 4, 11, 210/211, 820; MEDDEV / MDCG, MPG / MPDG, MDD, 93/42/EWG, MDR/IVDR 2017/745-746; MDSAP; Gebrauchstauglichkeit (Usability / Human Factors and Usability Engineering gemäß IEC 62366 / FDA CDRH); DIN EN ISO 13485:2012/2016; Audits / Inspektionen z.B. durch die FDA; Regulatory Affairs, z.B.: Medical Devices (510(k), ehem. STED Format), Pharma CMC Part – Modul 3, Combination Products / Companion Products, Phyto-Pharmazeutika, z.B., Zulassung in Deutschland, Europa, USA, Japan, Korea, Canada, Australien, Brasilien; Arbeits- und Organisationspsychologie, Kommunikation, Stress-Management Schulungen, Auditpsychologie und Audit Schulung für Mitarbeiter / Auditoren, firmeninterne Schulungen & Dozentin für Qualitätsmanagement.
Projekthistorie
02/2023
-
bis jetzt
Preparation of GMP documentation: ATMP, clean room environment
03/2023
-
bis jetzt
Quality Management
anonym
(Pharma und Medizintechnik, >10.000 Mitarbeiter)
Support and optimization QM System
10/2022
-
02/2023
Quality Management; Regulatory / CMC
anonym
(Pharma und Medizintechnik, 50-250 Mitarbeiter)
Compilation of an FDA Master File, ATMP
10/2018
-
12/2022
Quality Management
anonym
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Concept and implementation of an evaluation system for reprocessing of reusable medical devices (cf. FDA
„Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling“; ISO
17664:2017; Recommendation from the Commission on Hospital Hygiene and Infection Protection at the
Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) on the "Hygiene
requirements for the reprocessing of medical devices"), MDR readiness, authoring of scientific / literaturebased
Peer Reviews, Reporting; Biocompatibility Assessment for Implants. Biocompatibility Evaluations
(extractables/leachables), according to ISO 10933 for a series for polymer implants, together with a
toxicologist, including interpretation of MS spectra measured by a contract lab (evaluation reports); answering
deficiency letters of notified body.
„Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling“; ISO
17664:2017; Recommendation from the Commission on Hospital Hygiene and Infection Protection at the
Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) on the "Hygiene
requirements for the reprocessing of medical devices"), MDR readiness, authoring of scientific / literaturebased
Peer Reviews, Reporting; Biocompatibility Assessment for Implants. Biocompatibility Evaluations
(extractables/leachables), according to ISO 10933 for a series for polymer implants, together with a
toxicologist, including interpretation of MS spectra measured by a contract lab (evaluation reports); answering
deficiency letters of notified body.
09/2020
-
09/2022
Quality Management; Regulatory / CMC; Organizational Change Management
anonym
(Pharma und Medizintechnik, >10.000 Mitarbeiter)
Gap-analysis and optimization of QM system, with regard to FDA / IVDR readiness (Medical Device
manufacturer); support URS, selection process and customizing of new CAPA software and procedure;
supporting preparation of 510(k) documents and technical documentation, Intended Use (Product Claim) acc.
to IVDR / MDR Article 7 for various products; application of IVDR/MDR rules for correct registration according
to Product Claim and advice regarding content of IFU, labelling; conducting online-trainings on QM topics and
internal audits according to ISO 13485:2016; project lead and final project evaluation (questionnaire)
manufacturer); support URS, selection process and customizing of new CAPA software and procedure;
supporting preparation of 510(k) documents and technical documentation, Intended Use (Product Claim) acc.
to IVDR / MDR Article 7 for various products; application of IVDR/MDR rules for correct registration according
to Product Claim and advice regarding content of IFU, labelling; conducting online-trainings on QM topics and
internal audits according to ISO 13485:2016; project lead and final project evaluation (questionnaire)
04/2018
-
07/2021
Quality Management
anonym
(Pharma und Medizintechnik, 50-250 Mitarbeiter)
Concept and implementation of a QM System for a Pharmaceutical Entrepreneur / Distributor, preparation of a
tailored Quality Manual, SOPs, Supplier / Contract manufacturer Audits, Regulatory Audits, GDP, responsible
external QM Manager, communication with local authorities.
Audits, due to Corona pandemic remote audits:
tailored Quality Manual, SOPs, Supplier / Contract manufacturer Audits, Regulatory Audits, GDP, responsible
external QM Manager, communication with local authorities.
Audits, due to Corona pandemic remote audits:
- 06/2020: contract manufacturer qualification as document & online audit (manufacturer, regulatory, QM
- and general services)
- 09/2020: contract manufacturer qualification as document audit & video audit (manufacturer in France,
- GMP/GDP)
- 11/2020: contract manufacturer qualification as document & video audit (archiving service)
- 04/2021: contract manufacturer qualification as document & video audit (logistics, GDP)
- 06/2021: selection process and qualification by questionnaire of pharmacovigilance contract service
- provider
- 06/2021: contract manufacturer qualification as online/video audit (manufacturer, GMP)
Reisebereitschaft
Nur Remote verfügbar
exali consult-Haftpflicht-Siegel
Das original exali consult-Haftpflicht-Siegel bestätigt dem Auftraggeber, dass die betreffende Person oder Firma eine aktuell gültige branchenspezifische Berufs- bzw. Betriebshaftpflichtversicherung abgeschlossen hat.
Versicherungsbeginn:
15.04.2018
Versicherungsende:
01.05.2026
