Apr 14, 2022 14:25
2 yrs ago
37 viewers *
German term
Prüfleiter
German to English
Medical
Medical: Pharmaceuticals
Context: Inspection/audit of a pharmaceutical plant
"Aufgetretene Abweichungen werden gemäß SOP in die Kategorien „kritisch" und „unkritisch" eingeteilt. Die Klassifizierung erfolgt durch den Prüfleiter oder die QS."
Test supervisor? Head of testing??
Does anyone know the established term for this in EN ( not principal investigator in this case!)?
"Aufgetretene Abweichungen werden gemäß SOP in die Kategorien „kritisch" und „unkritisch" eingeteilt. Die Klassifizierung erfolgt durch den Prüfleiter oder die QS."
Test supervisor? Head of testing??
Does anyone know the established term for this in EN ( not principal investigator in this case!)?
Proposed translations
(English)
| 4 +2 | Inspection Supervisor/Quality Inspection Supervisor/Quality Control Supervisor |
Dr. Christopher Kronen
|
| 5 +1 | Pricipal Investigator |
Johannes Gleim
|
| 4 | study director |
Emmanuel Mgbomeni
|
Proposed translations
+2
18 mins
Dr. Christopher Kronen
United States
United States
Native in English
Specializes in field
United States
THE WORD DOCTOR (German medical degree)
Native in: English 
Works in: German to English
Related KudoZ points
:
4
Selected
Inspection Supervisor/Quality Inspection Supervisor/Quality Control Supervisor
I have used the above at various times in the past. If you google pharmaceutical jobs you will see these three terms popping up very frequently.
Peer comment(s):
| agree |
Kim Metzger
: I like quality control supervisor. https://www.mendeley.com/careers/job/pharmaceutical-quality-...
4 hrs
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Thank you, Kim.
|
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| agree |
Donatello Wilhelm
21 hrs
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Thank you, Felipe.
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4 KudoZ points awarded for this answer.
Comment: "Thanks, Christopher!"
1 hr
Emmanuel Mgbomeni
Nigeria
Nigeria
Native in English
Specializes in field
Nigeria
Technical, medical , business & general
Native in: English (Variants: US, UK) , Igbo 
, Yoruba
Works in: English to Igbo, English to Yoruba, English to French, and 5 more.
study director
This term means study director or test manager. If you lookup pharmaceutical jobs in Germany on this site: https://de.indeed.com/Prüfleiter-Jobs?vjk=8b7e986d828ec77, you will see jobs related to this term.
Peer comment(s):
| neutral |
thefastshow
: Yep, you will find this term as well as principal investigator, but these jobs are generally about managing studies a client wants to be done. I think this is about audits and the job title would be different.
3 hrs
|
+1
4 hrs
Johannes Gleim
Native in German
40 years Engineer, 20 years translations
Native in: German
Works in: English to German, German to English, French to German, and 6 more.
Related KudoZ points
:
11
Pricipal Investigator
Two roles that are essential (and can work as stepping stones to further a career in clinical research) are the Clinical Trial Assistant (CTA) and Clinical Research Coordinator (CRC) positions. The CTA typically works in an office-based environment, where they track and file trial protocols and case reports, coordinate meetings and help with managing timelines and budgets; the CRC typically recruits patients, works at the research site, prepares the case report forms and manages data.
https://ocrc.net/how-to-become-a-clinical-researcher/
In many countries, the term principal investigator (PI) refers to the holder of an independent grant and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often used as a synonym for "head of the laboratory" or "research group leader".
https://en.wikipedia.org/wiki/Principal_investigator
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
:
The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.
https://research.wustl.edu/about/roles-responsibilities/clin...
Who Can be a Principal Investigator?
Section 505 of the Food, Drug, and Cosmetic (FD&C) Act{6} requires the FDA to ensure that the investigational drug will be provided only to investigators who are “experts qualified by training and experience to investigate a new drug.”
:
When the investigation is conducted by a team of individuals, the clinical investigator is the responsible leader of the team and is called the principal investigator.
https://acrpnet.org/2022/02/15/the-clinical-research-investi...
https://ocrc.net/how-to-become-a-clinical-researcher/
In many countries, the term principal investigator (PI) refers to the holder of an independent grant and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often used as a synonym for "head of the laboratory" or "research group leader".
https://en.wikipedia.org/wiki/Principal_investigator
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
:
The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.
https://research.wustl.edu/about/roles-responsibilities/clin...
Who Can be a Principal Investigator?
Section 505 of the Food, Drug, and Cosmetic (FD&C) Act{6} requires the FDA to ensure that the investigational drug will be provided only to investigators who are “experts qualified by training and experience to investigate a new drug.”
:
When the investigation is conducted by a team of individuals, the clinical investigator is the responsible leader of the team and is called the principal investigator.
https://acrpnet.org/2022/02/15/the-clinical-research-investi...
Peer comment(s):
| neutral |
thefastshow
: Yep, you will find this term as well as study coordinator, but these jobs are generally about managing studies a client wants to be done. I think this is about audits and the job title would be different.
34 mins
|
| agree |
Cillie Swart
: Yes Definitely. Thanks !! I've had this before a number of times...
1 day 14 hrs
|
Discussion
Wenn Du der Meinung bist, dass der betreffende von Lirka zitierte Absatz eine Erklärung eines Arbeitsablauf in einem Labor/Unternehmen darstellt und nicht in erster Linie hier mit dem als Kontext gegebenen externen GMP Audit und dem ausführenden Inspektor zu tun hat, hast Du dieses aber nicht klar kommuniziert.
Man kann daher Deinen Beitrag und hier geäußertes Verständnis nicht klar einordnen/erkennen, daher meine Infos.
Wenn hier, entgegen der bisher gemachten Angaben eine Position innerhalb eines/des von externen Auditoren zu untersuchenden Unternehmens/Labors gemeint ist, wären Principal Investigator bei US-Unternehmen für GLP-Aufgaben eher angebracht, während bei europäischen etc. Laboren im Allgemeinen noch der Study Director vorherrscht.
Man muss Dir zugute halten, dass es in Deutschland offensichtlich einige Verwirrung in dem Bereich gibt. Dieser Fraggle nennt sich jedenfalls auch Prüfleiter und macht GMP Audits:
https://www.xing.com/profile/Christian_Weber763
Du wirst den "Prüfleiter" aber selbst bei Dokumenten, die sowohl GMP als auch GLP enthalten, nur unter dem Abschnitt zu GLP finden. Trotz deutscher Vorliebe für Komposita gibt es in diesem Fall mMn keine andere Interpretation, als dass der von Lirka zitierte Satz schlicht wie eine typisch deutsche Beschreibung einer Aufgabenkette innerhalb eines Betriebes etc. klingt.
Zum Gegentest: Finde mir nur ein deutsches Dokument, bei dem das nicht so ist. Bin da gern offen für, bin mir nur sicher, da wird keiner fündig. Die Klassifizierung erfolgt nicht durch den Auditor, sondern eben intern und das wird in dem Report lediglich beschrieben. Es würde absolut keinen Sinn ergeben, warum entweder die QS oder der Prüfleiter etwas klassifizieren könnte. Ich denke, hier fehlt Einiges an Kontext, den du richtigerweise am Anfang schon angefragt hast.
(Und es gibt GLP-Inspektionen, also nicht rein intern:
https://www.lzg.nrw.de/pharmazie/sich_arznei/inspekt_pruef/i...
https://mobil.bfr.bund.de/cm/350/die-durchfuehrung-von-glp-i... )
Grüße
Desweiteren gibt es einen Unterschied zwischn GLP und GMP https://www.johner-institut.de/blog/regulatory-affairs/glp-g... ...
der Link hier ist noch ein bisschen besser :https://www.sawakinome.com/articles/products/difference-betw...
"Bei der 'Guten Laborpraxis,' kurz GLP, handelt es sich um ein Qualitätssicherungssystem, das in der präklinischen Phase angewandt wird, um Wirkstoffe unter bestimmten Umgebungseinflüssen über einen definierten Zeitraum zu testen...Der Prüfleiter ist verantwortlich für die Einhaltung der GLP-Grundsätze und das Budget. Das prüfende Personal führt eine erste Qualitätskontrolle gemäß dem Prüfplan durch. Das QS-Personal bildet die zweite Instanz bei der Qualitätskontrolle. Sie erteilt auch die endgültige Freigabe für die Standardarbeitsanweisung."
https://blog.binder-world.com/de/grundsaetze-gute-laborpraxi...
GLP is the same in English:
"FDA requires researchers to use good laboratory practices (GLP), defined in medical product development regulations, for preclinical laboratory studies."
https://www.fda.gov/patients/drug-development-process/step-2...
The other two are study director and quality assurance unit:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...
Best
GMP auditor would work too.
If however they employ someone from their own staff and not a third party to do the audit Prüfleiter could well be an principal investigator (more common in the US) or a study director (more often used in Europe) https://newdrugapprovals.org/2016/03/03/which-external-gmp-a...
Check what comes closest here, e.g. :
Internal Audit director https://www.indeed.com/q-Internal-Audit-Director-Pharmaceuti...
Head of internal audit : https://www.xing.com/profile/Rolf_Krahnert
Global Quality Audit Manager : https://www.stepstone.de/stellenangebote--Global-Quality-Aud...
etc.etc.... some more details would be nice