QA Specialist
vor 2 Wochen
**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.**
**QA Specialist (m/w/d)**
**YOUR TASKS AND RESPONSIBILITIES**
- Supervising upstream pharmaceutical manufacturing facilities for the production of parenterals and biopharmaceuticals
- Ensuring that manufacturing operations are carried out in accordance with Good Manufacturing Practice and accepted pharmaceutical rules and regulations as well as the preparation and updating of pharmaceutically relevant documents (manufacturing instructions according to -13 AMWHV, SOPs)
- Ensuring the execution of necessary validations of the manufacturing processes as well as the required initial and ongoing training of production personnel (-12 AMWHV) including initiation of measures in case of necessary changes within the scope of Change Control (BASICS)
- Monitoring of monitoring results including taking necessary measures in coordination with QA
- Preparation of Investigation Reports in case of process deviations in coordination with QA/QC
- Review of manufacturing records (according to GMP guideline chapter 2) as well as handling of complaints and preparation and follow-up of inspections and audits
- Ensuring GMP compliance within the scope of projects and processes as well as optimizing processes with regard to GMP compliance and economic efficiency (OAE)
- Managing the** **practical training of pharmacy trainees (-4 AAppO)
**WHAT YOU BRING WITH YOU**
- Completed studies in pharmacy with license to practice as a pharmacist (M/F/d)
- First professional experience ideally in the pharmaceutical industry in the field of manufacturing, testing and evaluation of pharmaceuticals
- Good knowledge of drug risk assessment as well as national and international regulations (drug law) and Good Manufacturing Practice (GMP)
- Confident in the use of data processing systems (MS Office)
- Ability to analyze technical processes and to derive target-oriented measures as well as to think in a networked manner
- Good organizational skills and excellent communication skills
- High degree of assertiveness, flexibility and initiative
- Strong quality and cost awareness
- Fluent German and good English skills, both written and spoken
**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.
**Location**: Germany : Berlin : Berlin
**Division**: Pharmaceuticals
**Reference Code**:786267
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