Sr. QA Specialist - GMP
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 Pharmaceutical organisation, based in Netherlands.
Reviewing and approving cGMP documents
Approving investigations assuring they are complete, accurate, technically justified with the required documented evidence including risk assessments
Managing, evaluating and approving changes assuring they are compliant
Tracking the overall status of all quality systems
Participating in the development/ revision of company policies/ guidelines/ procedures and implementation in the site;
Preparing and/ or reviewing performance metrics for quality systems
At least 7 years of experience
Knowledge of regulations in Production, Validation, Quality Assurance/ Control, Quality Systems
Knowledge of and experience with quality and compliance guidelines and manufacturing processes;
Self-starter and independent
Ability to influence co-workers and stakeholders
Fluent in both Dutch and English
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 make sure that that the company is compliant to EU legislation and you will be making the quality processes more efficient.Responsibilities
-Working with the site validation teams providing guidance in the strategy, planning, delivery and retirement several systemsReviewing and approving cGMP documents
Approving investigations assuring they are complete, accurate, technically justified with the required documented evidence including risk assessments
Managing, evaluating and approving changes assuring they are compliant
Tracking the overall status of all quality systems
Participating in the development/ revision of company policies/ guidelines/ procedures and implementation in the site;
Preparing and/ or reviewing performance metrics for quality systems
Requirements
Bachelor’s degree a life sciences related fieldAt least 7 years of experience
Knowledge of regulations in Production, Validation, Quality Assurance/ Control, Quality Systems
Knowledge of and experience with quality and compliance guidelines and manufacturing processes;
Self-starter and independent
Ability to influence co-workers and stakeholders
Fluent in both Dutch and English
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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