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Documentation Associate – GMP Compliance Packaging
medac groupResponsible for Master Data Management in pharmaceutical production while ensuring compliance with GMP guidelines. Act as Key User for ERP system and support SAP implementation in Germany.
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Responsibility for operational Master Data Management in the production environment, ensuring consistent compliance with dossier requirements, country-specific regulations and applicable GMP guidelines
- Serve as Key User for the ERP system with a focus on Master Data Management, including preparation of validation documents
- Support the implementation of SAP with a focus on MDM
- Create and revise cross-functional GMP governing documents, e.g. SOPs and manufacturing instructions (Master Batch Records)
- Conduct document and data research, e.g. to support the handling of Quality Events
- Develop and define KPIs
Requirements
What you’ll need- Successfully completed commercial training (kaufmännische Ausbildung) or an equivalent qualification
- Several years of relevant professional experience in the pharmaceutical sector
- Solid knowledge of GMP
- Strong analytical skills and a structured way of working
- Experience working with the SAP ERP system
- Careful attention to detail and enthusiasm for working with Master Data Management systems and processes
- Team player with very good communication skills
- Willingness to work at both our Wedel and Tornesch locations
- Fluent German and very good English skills
Benefits
Comp & perks- Flexible and autonomous: in many areas of the company employees can arrange their working hours freely – and work remotely up to 60%
- 30 days of vacation per year and holiday pay
- Performance-based bonus payments
- Company pension plan and capital-forming benefits (vermögenswirksame Leistungen)
- Attractive additional benefits ranging from Corporate Benefits programs and accident insurance to external employee counseling
- Diverse range of development and training opportunities including language courses and e-learning
- Varied selection of tasty meals in the company restaurants in Wedel and Tornesch
- Subsidy for the Deutschlandticket and BusinessBike leasing for maximum flexibility
- Large selection of sports activities and health offers
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Master Data ManagementGMP KnowledgeKPI DevelopmentDocument ResearchValidation Document Preparation
Soft Skills
Strong Analytical SkillsAttention to DetailTeam PlayerVery Good Communication Skills
Certifications
Commercial Training (Kaufmännische Ausbildung) or Equivalent Qualification