CMO Manager
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Onze klant is een professionele organisatie in , Netherlands.
Provide effective oversight of manufacturing operations at the CMOs
Review and approve CMO batch records, validation reports, test data package, deviations, and change controls.
Evaluate and investigate manufacturing and lab deviations.
Interface with CMO’s QA regarding any potential compliance gaps, significant/major deviation resolution and regulatory inspections.
Manage required disposition activities needed for release of raw material, drug substance, drug product and finished goods.
Develop, negotiate, and maintain the quality technical agreements
Experience with batch record review and release.
Strong experience with leading and managing quality investigations.
Knowledge of Risk Management tools.
Strong working knowledge of cGMPs requirements
Experience in managing CMOs and driving process improvements.
Strong auditing experience.
Ability to travel approximately 50% of the time.
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
The Company
.Role Description
In this role you will be based in Holland but will be travelling a lot of the time. Find below the descriptions.Responsibilities
Provide oversight of the CMOs quality management systemProvide effective oversight of manufacturing operations at the CMOs
Review and approve CMO batch records, validation reports, test data package, deviations, and change controls.
Evaluate and investigate manufacturing and lab deviations.
Interface with CMO’s QA regarding any potential compliance gaps, significant/major deviation resolution and regulatory inspections.
Manage required disposition activities needed for release of raw material, drug substance, drug product and finished goods.
Develop, negotiate, and maintain the quality technical agreements
Requirements
Demonstrated experience in pharmaceutical/biopharmaceutical drug substance operationsExperience with batch record review and release.
Strong experience with leading and managing quality investigations.
Knowledge of Risk Management tools.
Strong working knowledge of cGMPs requirements
Experience in managing CMOs and driving process improvements.
Strong auditing experience.
Ability to travel approximately 50% of the time.
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
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