Pharma

Pharma

Batch Documentatie Specialist

9052 ZWIJNAARDE
Optie vast contract
Bachelor
35 u/week
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Functieomschrijving

For our client, a biotech company located in the Ghent area, we are looking for an administrative employee. In this role, you will be responsible for the cycle of documents linked to the production process. Every step must be documented and archived. You will have an important responsibility to ensure that everything runs strictly according to procedures:

  • Communicate about the up-to-date status of reviews and update status tracking spreadsheets.
  • Assist in correcting errors in documents, in line with GMP (Good Manufacturing Practices) and SOP (Standard Operating Procedure) guidelines.
  • Provide documents such as batch records, labels, forms, and ensure that these are printed and available for production.
  • Perform an initial quality control check on available batch records and verify the completeness of all documents.
  • Search for documents in the archives to meet customer requests.
  • Assist with audits (both internal and external) and collaborate closely with quality staff to promote data integrity and GMP compliance.
  • Initiate further investigation when product non-conformity occurs or when deviations are identified.

*Documents related to the release, assessment, approval, and alignment of a batch; a batch creation is a step-by-step production process where a pharmaceutical product is made.

Profiel

For this administrative role, we are looking for someone with a strong sense of responsibility and excellent attention to detail skills:

  • You have a degree in a relevant field or necessary technical affinity or experience. A Bachelor's or Master's degree, or relevant experience, is required.
  • Excellent communication skills in English (both written and spoken).
  • Proficient in the MS Office package with the ability to quickly learn new software.
  • A First-Time Right and hands-on approach with the mental flexibility to switch between tasks and re-prioritize when necessary.
  • Strong organizational skills.
  • Good teamwork abilities and the ability to quickly and accurately pass on important information to the correct department.
  • Ability to function well in a fast-changing environment, where deadlines are critical, and flexibility is a must.
  • Willingness to work in a rotating shift system; you work for 4 days and then have 4 days off. The different shifts are (6 am - 4 pm, 7 am - 5 pm, and 8 am - 6 pm). Due to the rotation, you will work an average of 50% of weekends.

Aanbod

For this administrative role as a batch record reviewer, you can expect several attractive benefits:

  • After a 6-month probation period, you will receive a permanent contract.
  • Salary will be adjusted to your level of education, and supplemented with meal vouchers of €7/day.
  • You will receive shift premiums: early shifts 9%, day shifts 4% (exception for starting at 10:00 am = 6%).
  • With your permanent contract, you will also receive group and hospitalization insurance.
  • You will work for a company that has developed a revolutionary cancer treatment.
  • You will become part of the operations team, working closely with the quality department.

Bedrijfsinfo

Our Client is a biotech company located in Zwijnaarde.

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Start People Gent GT
+32 (0)9 269 37 20
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