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 Noord-Brabant Netherlands.

The Company

They are committed to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Role Description

You will be responsible for QA guidance and support in the production area, perform batch record review, contract manufacturers and establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person.

Daily basis: supporting production, solving issues (problem solving production), signed to certain production line, batch record and documentation, involved in deviations and performing batch record reviews, GMP compliance, working together with maintenance team.

Responsibilities

- Providing guidance and support to Production staff (compliance with SOPs and Work Instructions)
- First point of contact for Quality related production questions during packaging and labeling operations
- Reviewing and approving batch production record data entries, deviation records and test protocols
- Performing finished product checks
- Approving Maintenance Work Orders
- GMP compliance checks and assisting in GMP training
- Prepare weekly/monthly metrics

Requirements

- MBO or BSc in Life Sciences or related area
- 2+ years of experience in QA or manufacturing in the Pharma/Medical Devices industry
- Experience in Batch record review and investigations, GMP, GDP or GCP experience
- Fluent in English

Other information

Soft skills: enthusiastic, motivated, flexible, good communicator, courage and able to stand up and make decisions. It's a very diverse team in nationality/age/background.

The candidate must be able and willing to work in 3 shifts.

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