You ensure quality assurance in sterile manufacturing by overseeing compliance with GMP processes, managing deviations, and supporting audits while facilitating the implementation of new products.
Anforderungen
- •Master in Biology or Chemistry
- •3+ years of operating experience
- •2+ years in pharmaceutical development
- •Experience in monitoring sterile processes
- •Know-how of electronic document management
- •Experience with pharmaceutical quality systems
- •Knowledge of regulatory guidelines
- •Fluent in German and English
- •Strong communication ability in challenges
Deine Aufgaben
- •Support go-live and routine manufacturing for parenteral products.
- •Oversee GMP processes and approve relevant SOPs.
- •Review batch records and prepare product documentation for release.
- •Act as shop floor QA and manage deviations and change controls.
- •Implement new parenteral products while ensuring local quality compliance.
- •Ensure processes meet regulatory requirements and quality standards.
- •Support site audits and inspections by authorities and self-inspections.
Deine Vorteile
Diverse backgrounds and perspectives
Commitment to excellence and innovation
Access and growth opportunities
Culture of inclusion and belonging
Original Beschreibung
# Quality Assurance Expert - Sterile Manufacturing (all genders)
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
**Your Role**
As a member of the Site Quality Darmstadt Development team, you will be responsible as Quality Assurance Expert to support the go-live and routine manufacturing in the Technical Development Center at Darmstadt site for parenteral products intended for clinical studies.
In this role you will oversee all manufacturing relevant GMP processes, review and approve the relevant SOPs, perform batch record review including aseptic process validation runs and prepare the product batch documentation for the release step by QP, act as shop floor QA in the plant and be involved in deviation and change control management.
You support the implementation of new parenteral products in the Technical Development Center overseeing local quality requirements.
Further responsibilities include assurance of compliance of processes and products with regulatory requirements and quality standards, including communication with internal and global interfaces in Healthcare Quality.
It will be part of your duties to support site related audits and inspections by competent authorities as well as self-inspections on site.
**Who you are:**
* Master in Biology, Chemistry other Scientific discipline or adequate professional experience or Approbation as pharmacist
* 3+ years of operating experience in pharmaceutical GMP manufacturing of parenteral products
* 2+ years of experience in pharmaceutical development environment
* Experience in monitoring and evaluation of sterile manufacturing processes
* Know-how of electronic document management systems (Mango, Trackwise, etc.) as well as electronic manufacturing execution systems (MES/ERP)
* Experience with methods and concepts of pharmaceutical quality systems
* Knowledge of governmental regulatory guidelines and regulations relating to the manufacturing of pharmaceuticals
* Fluent in German and English
* Strong ability to communicate even in challenging situations, team oriented, outcome-oriented personality
**What we offer:** We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Stellenanforderungsnummer:
290263
Standort:
Darmstadt
Berufserfahrung:
D - Berufserfahrung (4-9 Jahre)
Arbeitszeitmodell:
Vollzeit oder Teilzeit möglich
**Stellensegment:**
Pharmaceutical, QA, Quality Assurance, Medical Research, Clinical Research, Science, Technology, Quality, Healthcare