Scientific Documentation Specialist

Vor 4 Tagen


Mannheim, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

Company Overview:

GULP – experts united is a renowned client located in the vibrant economic area of Mannheim, standing for pioneering technologies and a progressive working environment.

Salary: Attractive salary and long-term job security through group affiliation, with an estimated annual salary range of €60,000 to €80,000 based on industry standards.

Job Description:

We are seeking a Scientific Documentation Specialist to further develop cutting-edge technologies and optimize processes in a dynamic team. The ideal candidate will have expertise in batch documentation and be responsible for reviewing batch documents, checking completed HABs for GMP-compliant documentation, and strictly adhering to the OLT incl. tracking and requesting required HAB accompanying documents.

Responsibilities:

  • Review of batch documents
  • Checking the completed HABs for GMP-compliant documentation including prompt correction in electronic batch review systems
  • Strict adherence to the OLT (Order Lead Time) incl. tracking and requesting the required HAB accompanying documents
  • Collaboration in the processing of measures from GMP requirements
  • Support with GMP audits
  • Support with actions for inspections or QRBs/DRs (e.g. HAB searches in the archive)
  • Revision and creation of documentation-relevant SOPs and implementation of related training courses
  • Electronic recording and evaluation of batch data
  • Participation in process optimization to improve good documentation practice and continuous error reduction
  • Preparation and printing of batch documentation

Requirements:

  • Succesfully completed scientific studies or completed training as a pharmacist/chemist (m/f/d) or comparable training
  • Sound professional experience in the manufacture of parenterals desirable
  • Good knowledge of GMP regulations and GMP-compliant documentation as well as knowledge of hygiene in the pharmaceutical environment
  • Sound knowledge of IT systems (MES, SAP, Excel, Word)
  • Very good knowledge of German and good knowledge of English

Benefits:

  • Attractive salary and long-term job security through group affiliation
  • Up to 30 days vacation per year
  • Contribution to company pension scheme after end of probationary period
  • Extensive social benefits, including Christmas and vacation bonuses


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