Dokumentationsmitarbeiter 1 BRM TG (m/w/x) -Befristet
Core
Prepare and compile documentation for internal and regulatory batch release, coordinate with external labs and authorities, and manage data in LIMS/SAP for a pharmaceutical manufacturing environment.
Role type
Documentation Specialist (Quality Assurance)
Builds
Regulatory release documentation, analysis certificates, and batch records for plasma-derived products.
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Data entry and verification, LIMS usage, SAP operations, report generation, regulatory compliance knowledge, document management, coordination with external stakeholders, SOP creation, data analysis.
Preferred skills
Database knowledge, English (Level 1), experience with 3PL distribution logistics.
Responsibilities
Prepare and merge documents for batch release, verify document completeness and plausibility, create and check reports from LIMS, monitor batch deadlines, coordinate sample shipment to external authorities, coordinate purchase goods release activities, perform SAP bookings for test lots, coordinate workflows with other departments, capture and authorize external lab results, create and authorize documentation for plasma intermediates, coordinate EU batch release activities, communicate with European offices and customers, verify batch data from LIMS/SAP, create and validate analysis certificates, compile data per customer requirements, update requirement catalogs, handle RA and KliFo inquiries, create SOPs, prepare data for inspections and audits, set new measures in SAP release management tool, verify authority invoices.
Seniority
Junior to Mid-level, 1-3 years experience
