Validation Specialist
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Noord-Holland Netherlands.
The company is globally known for specialising in manufacturing and distributing products for pain treatment and diagnostic procedures.
ROLE DESCRIPTION
You will be working on the QA department and you will coordinate the validation and qualification process. You will also be responsible for checking the documented proof which shows that new and amended company and production processes are aligned with the demanded requirements, laws and regulations.
RESPONSIBILITIES
Preparing Validation (Projects)
-Setting up and asses validation plans
-Mapping the demands on regulations, policies, norms and guidelines
-Executing and assessing risk analyses
-Doing inspections at suppliers
-Assessing change proposals, procedures, contracts and assignments
-Assessing specification documents that will serve as a base for the purchase of analyse or production resources
Realising Validation (Projects)
-Verifying evidence materials and test results
-Supporting the projectteams
-Monitoring and documenting progress of projects
-Advising and supporting the organisation on expanding the knowledge of validation, guidelines, policy agreements and pharmaceutical rules and regulations
Setting up reports and documentation
-Checking reports
-Initiating and contributing to policy documents and work guidelines
REQUIREMENTS
-At least a Bachelor degree, in a technical or chemical area
-Specialist knowledge of validation methods and corresponding demands
-Experience with validation and qualification studies to interpret the gotten results
-Sufficient knowledge of pharmaceutical guidelines, rules and regulations
-Good knowledge of quality systems and techniques
-Knowledge of company processes, devices and machines (for example sterilisation and aseptic processes)
-Excellent Dutch and English language skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Klaas-Jan van Duin.
