Project 55178 – Request for sterile auditor in France



pharmatch

JOB DESCRIPTION

Contract Type

Candidate (Freelancer)

Company Type

Biotech

Company Size

Startup < 100


Requested Expertise

Quality / Clinical study / Clinical development /

Profile Required

– Sterile GMP auditor (Pharmaceutical industry)
– Specialized : GMP part 1, Current Annex 1, LD13
– French speaking
– Knowledge about sterilizing filtration
– Knowledge on clinical studies phase 2 (investigational drug product) would be appreciated

Project Description

– We are looking for an auditor (specialized in production of sterile drugs) to carry out an audit at one of our subcontractors.
– The production site is located in France. We are aiming to qualify this site for the production of an experimental drug which will be used for a clinical trials phase 2.
– Our project include : Audit preparation, create the agenda for the audit according to the expected scope, 2 days audit on site , Audit report writing, Review of the CAPA plan
– Current audit date proposition from the production site : 12th & 13th of December 2023

Therapeutic Area

N/A

Language

English,French

Hard Skills

Soft Skills

Seniority Level

Experience 5 – 10 years,Experience > 10 years


Starting Date

2023-11-19

Project Duration

2 months

FTE / nb of days per week

1

Project Location

Limoges , France

Remote Flexibility

Yes

Travel Expected

Yes

Approximative Budget

Any other information of interest

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