- You communicate up-to-date status reviews, and update status tracking spreadsheets.
- You assist in the correction of errors in the documents in line with GMP (= good manufacturing practices) and SOP (= standard operating procedure) guidelines.
- Providing documents such as batch records*, labels, forms, ... You ensure that these are printed out and available for production.
- You perform a first quality check on already available batch records and you also check the completeness of all documents.
- Looking up documents in the archives in order to meet customer demands.
- Assist with audits (internal & external) and work closely with quality staff to promote data integrity and GMP.
- Initiate further investigation when product non-conformances or discrepancies occur.
- You have a Bachelor's or Master's degree or relevant experience.
- You have excellent communication skills in English (written & spoken).
- You can work fluently with the MS Office package, and you can learn new programs fluently.
- First Time Right and hands-on approach with the mental flexibility to switch between different tasks and reprioritize as needed.
- You have strong organizational skills.
- You are someone who can work well together and always relay important information quickly & correctly to the appropriate department.
- You can function well in a fast-paced environment, where deadlines are critical, and flexibility is a must.
- You can work in a rotating shift system; you work 4 days and then you are home 4 days. The different shifts are (6am-16pm, 8am-18pm, 10am-20pm, 12pm-22pm and 2pm-24pm). Due to the rotation, you will work an average of 50% on weekends.
- You have a Bachelor's or Master's degree or relevant experience.
- You have excellent communication skills in English (written & spoken).
- You can work fluently with the MS Office package, and you can learn new programs fluently.
- First Time Right and hands-on approach with the mental flexibility to switch between different tasks and reprioritize as needed.
- You have strong organizational skills.
- You are someone who can work well together and always relay important information quickly & correctly to the appropriate department.
- You can function well in a fast-paced environment, where deadlines are critical, and flexibility is a must.
- You can work in a rotating shift system; you work 4 days and then you are home 4 days. The different shifts are (6am-16pm, 8am-18pm, 10am-20pm, 12pm-22pm and 2pm-24pm). Due to the rotation, you will work an average of 50% on weekends.
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Start People Gent (Orban) Zwijnaarde, België Optie vast contractDescriptionVoor onze klant, een biotech bedrijf regio Gent, zijn we op zoek naar een administratief bediende. In deze functie ben je verantwoordelijk voor de cyclus van documenten gelinkt aan het productieproces. Elke stap moet gedocumenteerd en gearchiveerd worden. Je hebt een b ...
Administratief bediende - Zwijnaarde, België - Start People Gent (Orban)
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Beschrijving
DescriptionFor our client, a biotech company in the region of Ghent, we are looking for an administrative assistant. In this position you are responsible for the cycle of documents linked to the production process. Each step has to be documented and archived. You have an important responsibility to ensure that everything is done strictly according to the procedures:
*documents regarding batch issuance, review, release and reconciliation; batch creation is a step-by-step manufacturing process involving the creation of a pharmaceutical product.
Our client, based in Zwijnaarde, is a global biotechnology company bringing an innovative cell therapy to Ghent. With this, their team makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases. They are currently in a phase of strong growth and are looking for motivated and dedicated team members.
ProfileFor this administrative position, we are looking for someone with a strong sense of responsibility and excellent detail-oriented skills:
For this administrative position, we are looking for someone with a strong sense of responsibility and excellent detail-oriented skills:
