Quality 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!Our client is a professional organisation, based in Netherlands.
CMO compliance through output from audits.
Identify and agree on improvement actions
Create, negotiate and maintain Quality Agreements
Review, evaluate, and contribute to investigation
Assess any change control
Review and evaluate complaints
Review and approve the product quality review
Review and analyse the trend associated to stability results
Review and approve protocol and validation report
Minimum of 10 years related pharmaceutical industry
Experience in CMOs management
Thorough working knowledge of regulatory requirements
Extensive knowledge of GMP
Experience in auditing in GMP/GDP/ISO environments
Experience with Regulatory and ISO inspections
Excellent verbal and written communication skills ability to present effectively to groups.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Seppe Verhoeven.
The Company
.Role Description
In this role you will be responsible for the entire product groupResponsibilities
Monitoring and review of partners quality performCMO compliance through output from audits.
Identify and agree on improvement actions
Create, negotiate and maintain Quality Agreements
Review, evaluate, and contribute to investigation
Assess any change control
Review and evaluate complaints
Review and approve the product quality review
Review and analyse the trend associated to stability results
Review and approve protocol and validation report
Requirements
Scientific Degree with a professional qualification and QP statusMinimum of 10 years related pharmaceutical industry
Experience in CMOs management
Thorough working knowledge of regulatory requirements
Extensive knowledge of GMP
Experience in auditing in GMP/GDP/ISO environments
Experience with Regulatory and ISO inspections
Excellent verbal and written communication skills ability to present effectively to groups.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Seppe Verhoeven.
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