Agns Andouillet Email & Phone Number | My background is QC (approx. 20 years) where I had to supervise the activities of a small team of 4 to 5 QC technicians and was then responsible of the tech transfer from external laboratory and qualification of analytical methods . During approx. 8 years, I worked in the Quality Assurance department, where I had to manage a team of Quality specialists for QA documentation handling, customer complaints handling, shipping, GMP production of drug substance, drug product and finished product (packed product for distribution to pharmacy) , supplier quality management, QTAs, Audits, batch release and recall procedure). During this period, I provided the support to ensure the appropriate handling of deviation reports and change control to ensure compliance of commercial products to worldwide regulations. I used to actively participate to the health authorities inspections. During 2 years, I took the opportunity of a job rotation and joined PMO team to ensure the coordination of aseptic production for clinical trials, from the raw material management to the release of batches for shipping to CTS subcontractors. The risk analysis process, according to FMEA methodology was routinely used to ensure adequate action plan for implementation and appropriate qualification of the aseptic process for production. Then I came back to QA, as Drug Substance Release Manager (2 years). In this position I supported Biotech production department , for commercial purpose and IMPs , with the support of a small team of 4 QA Specialists and engineers. Duties were documentation review and approval (procedures, MBR, manufacturing process validation protocols and reports, deviation, change control, APR, ...) as well as supplier's audit, QA on the floor, inspection preparation (until May 2017). My current function, in between QA, QC and RA, is now dedicated to support QC Team to ensure compliance to Pharmacopeias and registered files.

Agns Andouillet

My background is QC (approx. 20 years) where I had to supervise the activities of a small team of 4...
Lausanne, Vaud, Switzerland

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Agns Andouillet’s Email agnes.andouillet@merckgroup.com

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Agns Andouillet’s Location Lausanne, Vaud, Switzerland

Agns Andouillet’s Current Industry Merck

Agns Andouillet’s Prior Industry Serono Laboratoires Aubonne

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Work Experience

Merck

QA Operational Associate Manager

2022-02-01 00:00:00 - Present

Serono Laboratoires Aubonne

Documentation & Release Manager

2005-05-01 00:00:00 - 2006-09-01 00:00:00

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FAQ About Agns Andouillet

Agns Andouillet is located at
Lausanne, Vaud, Switzerland

Agns Andouillet is a My background is QC (approx. 20 years) where I had to supervise the activities of a small team of 4 to 5 QC technicians and was then responsible of the tech transfer from external laboratory and qualification of analytical methods . During approx. 8 years, I worked in the Quality Assurance department, where I had to manage a team of Quality specialists for QA documentation handling, customer complaints handling, shipping, GMP production of drug substance, drug product and finished product (packed product for distribution to pharmacy) , supplier quality management, QTAs, Audits, batch release and recall procedure). During this period, I provided the support to ensure the appropriate handling of deviation reports and change control to ensure compliance of commercial products to worldwide regulations. I used to actively participate to the health authorities inspections. During 2 years, I took the opportunity of a job rotation and joined PMO team to ensure the coordination of aseptic production for clinical trials, from the raw material management to the release of batches for shipping to CTS subcontractors. The risk analysis process, according to FMEA methodology was routinely used to ensure adequate action plan for implementation and appropriate qualification of the aseptic process for production. Then I came back to QA, as Drug Substance Release Manager (2 years). In this position I supported Biotech production department , for commercial purpose and IMPs , with the support of a small team of 4 QA Specialists and engineers. Duties were documentation review and approval (procedures, MBR, manufacturing process validation protocols and reports, deviation, change control, APR, ...) as well as supplier's audit, QA on the floor, inspection preparation (until May 2017). My current function, in between QA, QC and RA, is now dedicated to support QC Team to ensure compliance to Pharmacopeias and registered files.