SIRE® 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 Utrecht Netherlands.

The Company

Part of an international organisation, specialising in the production of APIs, Drug Products, and associated Packaging Services. A dedicated professional team ensure the highest standards are pursued at all stages of development. Combined with a vertically-integrated supply chain model that provides development & manufacturing expertise spanning the complete GMP, translating into high-value products.

Role Description

As Senior Quality Assurance Specialist within the onsite team you will ensure that all products are manufactured in accordance with GMP. Develop GMP training packages and delivery of training. Working with the reporting manager, continuously improve QA and Compliance systems, investigate quality issues and using problem solving techniques to assure successful outcomes for the company and external Health Authority inspections.

Responsibilities

- Document approval
- Batch records review and approval
- Product release
- Approval of deviation and support to related investigations
- Provide Quality support for investigation
- Operate the change control system & CAPA system
- Review / approval of validation protocol / report
- Performing internal audits/inspections
- Assist with implementation and maintenance GMP training system in EU.

Requirements

- Min. Bachelor's degree Bio Sciences
- Min. 5 years’ experience as QA in GMP environment
- Languages: English (working knowledge)
- Identifying, writing evaluating and closing Deviations and CAPA
- Experience with Change Control practices/strategies
- Proficient in Outlook, MS Word, Excel, Power Point and other applications
- Excellent interpersonal, collaborative and organizational skills

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Turlough White.