Quality Specialist (all genders)

Bayer CropScience Limited; Berlin; Hybrid; EUR 77.000 - 94.000; Vollzeit

Benefits dieser Stelle

Hybrid-Arbeitsmodell

Kinderbetreuung

Fortbildungsmöglichkeiten

Gesundheitsangebote

Zusammenfassung

Bayer sucht eine/n Quality Specialist (all genders) in Berlin zur Sicherstellung GMP-konformer Herstellung parenteraler Arzneimittel. Sie erstellen und pflegen GMP-Dokumente, führen Veränderungen im Change Control durch und begleiten Audits.

Sie verfügen über ein Pharma-Studium mit Approbation und idealerweise erste Erfahrungen in der pharmazeutischen Produktion, Tests und Bewertung von Arzneimitteln. Deutsch fließend, Englischkenntnisse erwünscht, sowie Führungs- und Kommunikationsfähigkeiten.

Qualifikationen

• Pharmazie-Abschluss und Approbation als Apotheker.
• Erste Berufserfahrung in der pharmazeutischen Industrie bevorzugt.
• Kenntnisse in Risikobewertung von Arzneimitteln und GMP-Vorschriften.
• Gute IT-Kenntnisse, z. B. MS Office.
• Analytische Denkweise und systemorientierter Arbeitsstil.
• Organisationstalent und Kommunikationsstärke.
• Führungspotenzial und Belastbarkeit.

Aufgaben

• GMP-gerechte Herstellung und Dokumentation sicherstellen.
• Herstellungsprozesse validieren und Schulungen durchführen.
• Deviations-Investigationsberichte erstellen.
• Herstellungsprotokolle prüfen und Audits vorbereiten.
• Kostenbewusstsein und Prozessoptimierung.
• Praktische Schulung von Pharma-Studenten.

Kenntnisse

GMP-Kenntnisse

Analytische Fähigkeiten

Teamführung

Organisationstalent

Kommunikationsstärke

MS Office Kenntnisse

Deutsch fließend

Englischkenntnisse

Ausbildung

Pharmazie-Abschluss mit Approbation

Tools

MS Office

Jobbeschreibung

Quality Specialist (all genders)

YOUR TASKS AND RESPONSIBILITIES

• You manage pharmaceutical production facilities for the manufacturing of parenteral drugs
• You ensure that the execution of manufacturing processes is in accordance with GMP regulations and recognized pharmaceutical rules
• You regularly create and update pharmaceutical-relevant documents (e.g., manufacturing instructions according to §13 AMWHV, SOPs)
• In case of procedural deviations, you prepare Investigation Reports in coordination with QA/QC
• You ensure necessary validations of manufacturing processes as well as required initial and ongoing training of production personnel (§12 AMWHV) and you initiate measures within the framework of Change Control for necessary changes
• You review manufacturing protocols and handle complaints as well as the preparation and follow-up of inspections and audits
• In the context of projects and processes, you ensure GMP compliance optimize them regarding cost-effectiveness
• The supervision of practical training for pharmacy interns (§4 AappO) is also part of your responsibilities

WHO YOU ARE

• You have a degree in pharmacy with a license to practice as a pharmacist
• Ideally, you have gained initial professional experience in the pharmaceutical industry around manufacturing, testing, and evaluation of medicinal products
• You possess good knowledge of the assessment of medicinal product risks as well as of national and international regulations (pharmaceutical law) and you navigate confidently in the GMP environment
• You are proficient in IT systems such as MS Office
• You are able to analyze technical processes, derive targeted measures and to think in a connected, systems-oriented way
• You have good organizational skills and strong communication abilities
• Leadership qualities such as independent action, assertiveness, communication skills, flexibility, and resilience characterize you
• You bring a pronounced quality and cost awareness
• Fluent German language skills and good English skills, both written and spoken, round off your profile

ADDITIONAL INFORMATION

The position is a 12 - month fixed-term contract.

WHAT WE OFFER

• We ensure your financial stability with a competitive salary between 77.300€ and 93.800€ per year (full-time) plus a variable component. Your compensation is based on your qualifications, skills, and professional experience.
• Whether it’s hybrid work models or part-time arrangements: Whenever it is possible, you will have the flexibility to work how, when and where it is best for you.
• Your family is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more.
• We support your professional growth by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs.
• We promote health awareness and opportunities for selfcare through various measures, such as free health checks with the company doctor.
• We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location: Germany : Berlin : Berlin

Division: Pharmaceuticals

Reference Code: 887953