CQV Lead Engineer PM
- Verfügbarkeit einsehen
- 0 Referenzen
- 115‐125€/Stunde
- 4057 Basel
- Weltweit
- fr | de | en
- 31.01.2023
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
4/2022 – offen
Tätigkeitsbeschreibung
Performed activities:
‒ Responsible for the preparation and performance of requalification activities:
risk analysis, DQ, IQ OQ and PQ
‒ Preparation and performance of CSV Software-Test Protocol for packaging
control system according to CFR 21 Part 11
▪ Signum HR
▪ Signum 2DC
‒ Planning and management of qualification tasks with the operational team
‒ Preparation of qualification reports
‒ Review and approval of qualification documents
‒ Processing of CAPA Documents
‒ Temperature-Mapping and control of cooling utilities and storage room.
Responsible for the following systems:
‒ Steril sample cabin
‒ Clean room
‒ Autoclaves,
‒ CIP/SIP systems
‒ Sterilization Tunnel
‒ H2O2 sterilizer
‒ Isolator
Tools used: MS Office, MS Outlook, MS Excel, Testo-Software, DHC-Vision, SAP
Gute Herstellungspraxis (GMP), Qualitätsmanagement / QS / QA (IT)
10/2021 – 8/2022
Tätigkeitsbeschreibung
Performed activities:
‒ Documentation preparation of:
URS
FS
GMP Rsk Analysis
CQP
DQ
IQ
OQ
Traceability Matrix
‒ Responsible for following system:
Process-, and Media panel
Deep Freezer (- 70 °C)
Huber-Thermostat
Cooling Rooms
‒ Implementation and GMP-compliant documentation for the qualification activities.
‒ CQV Team leader of 4 Engineers
‒ Regular review meeting, control of timelines and communication between
Tools used: MS Office, MS Outlook, COMOS, DMS, SAP
Gute Herstellungspraxis (GMP), Qualitätsmanagement / QS / QA (IT)
1/2020 – 5/2021
Tätigkeitsbeschreibung
Activities performed during this time:
‒ Responsible for the area of pre- and post-treatment in the parenteral operation
(Leverkusen site)
‒ Creation of risk analysis documents
‒ Creation of qualification plan, protocol and reports for hot water spray sterilizers and
device sterilizers
‒ Independent implementation and GMP-compliant documentation of the qualification.
‒ Execution of Lamina Air Flow performance qualification
Tools used: MS Office, MS Outlook, LifeDoc, Basics, 4D, SAP, Dev @ com, MasterControl
Gute Herstellungspraxis (GMP), Qualitätsmanagement / QS / QA (IT)
3/2019 – 12/2019
Tätigkeitsbeschreibung
Activities performed during this time:
‒ Responsible for the qualification of Prodigy and laboratory cooling devices
‒ Organization of the production and approval of medical products •
‒ Responsible for the temperature monitoring system (Thermoguard)
‒ Carrying out supporting tasks in the clean room
‒ Used Tools: MS Excel, MS Word, MasterControl
Gute Herstellungspraxis (GMP)
1/2018 – 3/2019
TätigkeitsbeschreibungInterest calculation, interest refund
Eingesetzte QualifikationenBankwesen (allg.)
5/2017 – 6/2017
Tätigkeitsbeschreibung
Quality management: Process validation: BAXA Repeater pump failure point test for the injection of Vancomycin solution
- Learning how to work in clean rooms
‒ Development and validation of a filling method of sterile drugs into "IV bags" in clean
room
‒ Performance of the method validation procedure
‒ Creation of validation report
‒ Training of Employee
Tools used: MS Excel, MS PowerPoint, IBM Lotus Note,
Gute Herstellungspraxis (GMP), Qualitätsmanagement / QS / QA (IT)
4/2017 – 5/2017
Tätigkeitsbeschreibung
Biocompatibility:
‒ Support in the development and validation of analytical method for the examination of
plastic materials following the General Chapter <661.1>.
‒ Design of standard operating procedure.
‒ Research and compile list of all necessary reagents and materials for USP <661.1>
testing.
‒ Discussion with various representative information concerning TOC analyzers and
obtained quotes.
‒ Aid in the decision process whether to acquire new instrumentation
‒ Create tests procedures and related forms for USP <661.1> (Alkalinity/Acidity,
Sample Extraction and Absorbance)
‒ Complete training on FTIR analysis -Obtained information on blood mimicking
solutions for an engineering project
‒ Conduce testing for a chemical resistance study on new device, testing required
periodic introduction of various agents to devices and observing for physical changes.
Forschung & Entwicklung (allg.)
6/2016 – 9/2016
Tätigkeitsbeschreibung
Methodenentwicklung und -validierung zur Viskositätsmessung von Polysulfonlösung
• Entwicklung einer Methode zur Viskositätsprüfung mit dem Viskotester iQ der Firma ThermoFisher Scientific
• Durchführung sowie GMP-gerechte Dokumentation der Risikoanalyse
• Erstellung der Prüfplan zur Untersuchung der Richtigkeit, Präzision, Robustheit, Bestimmungsgrenze, Linearität, Empfindlichkeit Wiederholpräzision und Vergleichspräzision
• Durchführung und Dokumentation aller Schritten der GMP-gerechten Methodenvalidierung
• Erstellung von SOP bezüglich der neuen Methode
Prozessvalidierung
3/2016 – 5/2016
Tätigkeitsbeschreibung
GMP gerechte Gerätequalifizierung 3x Viskostester iQ der Firma ThermoFisher Scientific
Erstellung von:
- Qualifizierungsplan
- Risikoanalyse
- DQ
- IQ
- OQ
Durchführung der Qualifizierungsaufgaben
Erstellung von Qualifizierungsbericht
Prozessvalidierung, Qualitätsdokumentation
Weitere Kenntnisse
MS Office, MS Outlook, LifeDoc, Basics, 4D, SAP, Dev@com, COMOS, DMS
Persönliche Daten
- Deutsch (Fließend)
- Englisch (Fließend)
- Französisch (Muttersprache)
- Europäische Union
- Schweiz
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