Your mission
The position is initially limited to three years as a parental leave cover.
- Batch record review of manufacturing and testing protocols of biotechnologically produced active ingredients and finished dosage forms
- Responsible monitoring of GMP-compliant documentation for completeness, plausibility and correctness.
- Administration and GMP-compliant filing of manufacturing and test documents in our Document Management System (d.velop)
- Evaluation of quality key figures
- Preparation of batch-specific batch record review reports
- Participation in audits and self-inspections
- Communication with internal and external stakeholders as well as business partners
Your profile
- Successfully completed scientific training (e.g. PTA, BTA, CTA, etc.) or successfully completed scientific studies
- Very good GMP knowledge and knowledge of pharmaceutical documentation requirements
- Experience in the field of serialization desirable
- Good communication skills and the ability to formulate precisely and concretely
- Interest in reviewing documents and identifying any discrepancies
- Strong sense of responsibility and quality-oriented approach
- Very good knowledge of German and English is mandatory, Korean language skills are advantageous
Our Offer
- A job in an established and renowned family business that offers you the security of over 35 years in business as well as a personal and appreciative working atmosphere
- Flexible working hours and 30 days\‘ vacation
- Comprehensive training opportunities with a fixed annual training budget
- A modern working environment
- Various benefits such as JobRad, EGYM Wellpass, employee restaurant, regular events and much more.
- We have flat hierarchies and small teams without matrix structures. This enables us to have clear and direct communication channels that lead to fast decision-making processes
- We are looking for you as a personality and want you to make an authentic contribution – we encourage this in turn by giving you plenty of scope for creativity and independence
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Quality Manager (all genders) Batch Record Review – Biotechnological Products Arbeitgeber: Midas Pharma GmbH.
Midas Pharma ist ein etabliertes Familienunternehmen, das Ihnen eine persönliche und wertschätzende Arbeitsatmosphäre bietet, ergänzt durch die Sicherheit von über 30 Jahren Geschäftserfahrung. Unsere modernen, individuellen Büros fördern konzentriertes Arbeiten und Rückzugsmöglichkeiten, während flache Hierarchien und schnelle Entscheidungswege eine enge Zusammenarbeit ermöglichen. Wir legen großen Wert auf Ihre persönliche und berufliche Entwicklung und bieten zahlreiche Unterstützungsmöglichkeiten sowie Auslandseinsätze an, um Ihre Karriere voranzutreiben.
Kontaktperson:
Midas Pharma GmbH. HR Team