Freelancer profile translated to English.

Description

Consulting and project management in the field of medical technology and pharmaceuticals. Experience in the conformity assessment procedure for medical devices and personal protective equipment. Competent in system certification ISO 9001, ISO 13485 and GMP, as well as conducting and supporting audits (1st, 2nd, 3rd-party). Experience in risk management as a moderator.

Languages

German
Native or bilingual
English
Fluent

Workplace preferences

Remote only

Primarily works remotely

Dräger
Risk Manager
MEDICAL
January 2023 - Today (3 years and 7 months)
- Identification, analysis, evaluation, and documentation of product-related risks for medical devices according to ISO 14971 during product development
- Assessment of the safety relevance of hazards
- Implementation of risk minimization measures
- Risk management documentation for approvals and product qualifications
aphria RX GmbH
Quality Manager
PHARMACEUTICALS INDUSTRY
December 2021 - December 2022 (1 year and 1 month)
- Establishment and implementation of a quality management system (GMP, GDP, GACP)
Creation, coordination, and management of SOPs
- Support of central QM processes (management of deviations, CAPAs, and complaints)
- Conduct of self-inspections
- Conduct of GxP training as training officer
- Planning and coordination of qualification and validation activities
- Qualification of suppliers, service providers, and customers, including organization and execution of audits and their follow-up
- Planning and coordination of an efficient change control system
- Planning, moderation, and coordination of internal risk management (QRM)
Mark Malolepsy Consulting
Consultant Quality Management Medical Devices and GMP
MEDICAL
December 2020 - Today (5 years and 8 months)
Hamburg, Germany
Consulting and project management in the areas of ISO 9001, ISO 13485, MDR, MPG, Risk Management, Process Management, Post-Market Surveillance, and Conformity Assessments