QA Manager Global / Medicines sr. Associate
Location: BelgiumSIRE® 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 Flandre Orientale Belgium.
With third-parties you will make Quality Agreements (contract manufacturers, logistic service providers, distributors).
- Support technical transfers, qualification and validation work.
- Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers.
- Evaluate and follow-up Change Controls together with the Regulatory Affairs team..
- You will be part of Supplier Qualification and Regular Supplier Auditing.
- Provide QA training to the entire group regarding QA systems and processes and procedures and evaluate training effectiveness.
- You will support in the maintenance of the Quality Management System
- Support the internal QA audits
- At least 5 years relevant experience in QA in the pharmaceutical industry.
- Knowledge of and experience in ISO13485, ISO14971, HACCP, ISO 22716 is an advantage
- Strong project management skills & team worker in a multicultural environment.
- Regular international travelling (1 x/month) is inherent in this role.
- You speak and write fluently English. Other languages are an asset.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Amber Moet.
The Company
They are part of an international pharmaceutical group. The client has a product portfolio that includes pharmaceutical medicines, medical devices, cosmetics, food supplements and biocides. They are rapidly expanding.Role Description
In this position you will support the Global Quality Assurance Medicines team in maintaining the integrated Quality Management System for Medicinal products.Responsibilities
Your responsibility is to act according QA strategy, vision and standards. You wil represent QA of certain product categories and all QA matters associated.With third-parties you will make Quality Agreements (contract manufacturers, logistic service providers, distributors).
- Support technical transfers, qualification and validation work.
- Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers.
- Evaluate and follow-up Change Controls together with the Regulatory Affairs team..
- You will be part of Supplier Qualification and Regular Supplier Auditing.
- Provide QA training to the entire group regarding QA systems and processes and procedures and evaluate training effectiveness.
- You will support in the maintenance of the Quality Management System
- Support the internal QA audits
Requirements
- Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry or equivalent through experience.- At least 5 years relevant experience in QA in the pharmaceutical industry.
- Knowledge of and experience in ISO13485, ISO14971, HACCP, ISO 22716 is an advantage
- Strong project management skills & team worker in a multicultural environment.
- Regular international travelling (1 x/month) is inherent in this role.
- You speak and write fluently English. Other languages are an asset.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Amber Moet.
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