Batch Records Coordinator Pharma

il y a 4 jours


Gent, Belgique HAYS Temps plein

Ghent I Batch Records Coordinator Pharma I Bachelor/Master I English I Shiftsystem
**Your new company**
Our client in Ghent is a fast-growing international company that produces a biotechnological therapy for the treatment of various diseases. You can expect to be part of an innovative team working on treatments that have the potential to make a significant impact on patients’ lives.
**Your new role**
As a Batch Records Coordinator, you will be part of the Technical Operations team. You will be responsible for reviewing batch records for personalized cell therapies, supporting both clinical and commercial needs in a sterile cGMP environment. Here are your responsibilities:

- Making sure all related documentation is complete and follows our established policies and procedures for batch release.
- Conducting daily First Quality reviews within Operations for executed batch records.
- Keeping everyone in the loop with accurate and up-to-date status updates, updating status tracking spreadsheets, and preparing reports.
- Addressing and fixing any deficiencies in the reviewed documentation according to cGMPs and SOPs on a daily basis.
- Supporting process and internal audits whenever needed.
- Working closely with QA teams to promote data integrity and good documentation practices.
- Navigating various online platforms, including MES, SAP, COMET, and eLIMS.
- Regularly interacting with other departments to gather batch record information or resolve documentation issues.

**Your profile**
- A Bachelor’s degree in Science, Bio-Engineering, Pharmacy, or a related field, or equivalent experience is required.
- Experience in a cGMP or ATMP environment within the biotech/biopharma industry is preferred.
- Knowledge of GMP is advantageous.
- Ability to work shift schedules, including weekends is required.
- Proficiency in the MS Office Suite and the ability to efficiently manage multiple tasks.
- Capability to work independently after training and prioritize tasks effectively.
- Clear and concise verbal and written communication skills, with attention to detail and the ability to follow procedures.
- Fluent English is essential. Fluent Dutch is a plus

**What you'll get in return**
- International environment
- A meaningful job that contributes directly to the well-being of patients.
- An excellent work-life balance. You work 4 days, then you enjoy 4 days off.
- Competitive salary
- Meal vouchers of €7
- Insurance package

**What you need to do now**

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
1106255
**Accreditation number**

**VG 292/BUOSA W.INT.35 W.SO.35**

**Brussels n° 00322-406-20121217



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