Manufacturing GMP specialist | Biopharmaceuticals | Zuid-Holland
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 and Biotechnology organisation, based in Zuid-Holland Netherlands.
o inspection readiness, facilitating audits and inspections;
o continuous improvement of internal procedures;
o being key user in the documentation system, supporting in the creation of documents;
o being key user of the quality system, responsible for creation and on-time closure of change controls and quality investigations;
• Organizing drug product distribution to the different storage and clinical facilities;
• Keeping the oversight of the drug product inventory;
• Maintaining the training strategy and program for the department;
• Requesting purchase orders and facilitate the invoicing process.
- At least 4 years of experience in QA or aseptic drug product manufacturing is required, experience in (bio-) pharma industry is desirable.
- pro-active, has a strong quality mindset and works accurately.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
The Company
They are one of the biggest and most respected health care companies in the world. This company is dedicated to the development of novel therapeutics and vaccines to treat, cure and prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern such as polio and Ebola.Role Description
The Fill & Finish Process team is responsible for the external manufacturing of drug product. As Manufacturing GMP Specialist, you are involved in all GMP-related activities for the preparation, execution and follow-up actions of aseptic drug product manufacturing at the external drug product manufacturing sites. You work with different members of the project teams.Responsibilities
• Ensuring and maintaining the quality level of the group;o inspection readiness, facilitating audits and inspections;
o continuous improvement of internal procedures;
o being key user in the documentation system, supporting in the creation of documents;
o being key user of the quality system, responsible for creation and on-time closure of change controls and quality investigations;
• Organizing drug product distribution to the different storage and clinical facilities;
• Keeping the oversight of the drug product inventory;
• Maintaining the training strategy and program for the department;
• Requesting purchase orders and facilitate the invoicing process.
Requirements
- A MSc/BSc in pharmaceutical sciences or other relevant disciplines (i.e., pharmacy, (bio)chemistry).- At least 4 years of experience in QA or aseptic drug product manufacturing is required, experience in (bio-) pharma industry is desirable.
- pro-active, has a strong quality mindset and works accurately.
Other information
Please submit your application before the 27th of December.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
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