Quality Specialist (all genders)

Bayer AG; Berlin; Hybrid; EUR 77.000 - 94.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Hybrid work

Family daycare

Learning & development

Health checks

Inclusive environment

Zusammenfassung

Die Bayer AG in Berlin sucht eine/n Quality Specialist (all genders) zur Betreuung pharmazeutischer Produktionsanlagen für parenterale Arzneimittel. Sie arbeiten gemäß GMP und erstellen/aktualisieren Herstellanweisungen sowie SOPs.

Sie prüfen Abweichungen, koordinieren Investigations mit QA/QC, führen Validierungen durch und schulen Produktionspersonal. Change Control und Audit-Vorbereitungen gehören ebenfalls dazu.

Qualifikationen

• Abgeschlossenes Pharmazie-Studium und Approbation als Apotheker.
• GMP-Kenntnisse und regulatorische Kenntnisse.
• Gute MS-Office-Kenntnisse und Dokumentationsfähigkeit.
• Teamorientierte Arbeitsweise und Kommunikationsfähigkeit.
• Verständnis regulatorischer Anforderungen (Pharma).

Aufgaben

• Herstellung pharmazeutischer Produkte unter GMP-Richtlinien.
• Sicherstellung der Einhaltung pharmazeutischer Regularien.
• Erstellung und Aktualisierung relevanter Dokumente (z. B. Herstellanweisungen).
• Untersuchungsvorgänge bei Abweichungen in Abstimmung mit QA/QC.
• Durchführung von Validierungen und Schulungen des Produktionsteams.
• Überprüfung Herstellungsprotokolle und Auditvorbereitungen.

Kenntnisse

Analytisches Denken

Teamfähigkeit

Kommunikationsstärke

Führungskompetenz

Deutsch fließend

Englischkenntnisse

Ausbildung

Pharmazie-Studium

Approbation als Apotheker

Tools

MS Office

Jobbeschreibung

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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

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

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: What matters to you, matters to us!

• 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.

Be You. Be Bayer.

#LI-AMSEMEA

YOUR APPLICATION

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

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.