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Scientific Documentation Specialist
vor 1 Monat
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
