Projects
March 2024 - Ongoing
June 2023 - December 2023
(7 mos)
November 2022 - December 2022
(2 mos)
July 2022 - May 2023
(11 mos)
March 2021 - February 2023
(12 mos)
November 2021 - April 2022
(6 mos)
Qualification of Production Lines and Process Validation
Field: Single Dose Devices (Pens) for Treatment of Obesity.
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n/a
Qualification of laboratory equipment and Validation of Analytical Methods
Field: Haemostatic products and medical devices for healthcare professionals
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Responsible for qualification of laboratory equipment for QC analyses.
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Responsible for the validation of analytical method.
Statistics for setup of Clinical Trials
Field: Sleep Enhancement (Anti Snore)
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Statistical calculations of clinical trial setup to ensure sufficient sample sizes and power.
Interim Management, Stability Studies and Process Validation
Field: Medical Devices for Minimally Invasive Procedures.
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Support for new manager
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Responsible for the planning of tests and report writing for stability studies for MDR submission (MDD -> MDR remediation).
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Writing of several risk.based rationales for overdue re-validations.
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Responsible for several validations and re-validations.
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Writing of protocols.
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Data analyses (statistics).
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Writing of reports.
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Responsible for last round of answers for findings on the subject of validation from MDR-audit (Validation performed and response approved by TÜV/SÜD).
Stability Studies for MDR submission
Field: Haemostatic products and medical devices for healthcare professionals
Responsible for stability studies for MDR submission (MDD -> MDR remediation).
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Coordination with internal and external stakeholders.
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Writing protocols for the studies.
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Sourcing of suppliers and contractual negotiations.
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Writing of study reports.
QMS support for IVDR Stage II audit.
Field: AI-driven precision pathology; SaMD (Software as a Medical Device)
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Deviation handling.
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Support in connection with IVDR Stage II audit (passed by BSI).
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Writing of procedures for process validation.
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Rollout and training in above procedures (september 2022).
June 2023 - December 2023
(7 mos)
Qualification of laboratory equipment and Validation of Analytical Methods
Field: Haemostatic products and medical devices for healthcare professionals
-
Responsible for qualification of laboratory equipment for QC analyses.
-
Responsible for the validation of analytical method.
Projects
June 2023 - December 2023
(7 mos)
Qualification of laboratory equipment and Validation of Analytical Methods
Field: Haemostatic products and medical devices for healthcare professionals
-
Responsible for qualification of laboratory equipment for QC analyses.
-
Responsible for the validation of analytical method.