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How you will contribute:
Ensure the availability and current process guidelines, including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and forms, to maintain regulatory adherence of plasmatic (recombinant) product manufacturing at the Pharmaceutical Production Site I72 (LA24/F & LA91).
Oversee continuous adaptation and improvement of process guidelines and descriptions, in accordance with current regulatory standards such as GxP and EHS, clients and relevant partner departments.
Assume leadership role in unit projects for I72 (LA24/F & LA91), serving as a representative or lead.
Act as site and process representative during regulatory inspections, Audits, and guided visitor tours.
Application of Lean Management and Six Sigma tools
Close collaboration with the CAPA team to assure adequate investigations and support timely closure of CAPAs to assure customer supply
Gemba Walks and supervision of production and processes on demand and in line with department targets
Support implementation of new products and processes within the department.
Collaboration with cross-functional teams to optimize results and enhance the value streams associated with products.
What you bring to Takeda:
Experience within the pharmaceutical industry, food company or a process-orientend company is highly valuable.
Understanding of regulatory requirements, including Current Good Manufacturing Practices (cGMP) and other relevant regulations, is essential
Familiarity with QMS principles, including document control, deviations, CAPA (Corrective and Preventive Action), change control, and risk management, is of advantage.
Strong communication skills, necessary for collaborating with cross-functional teams, presenting process-related information to stakeholders, and addressing compliance or quality concerns.
Experience with internal and external audits, including AGES and FDA or other regulatory agency inspections, is of advantage
High proficiency in relevant software (MS office) and data analysis tools
Fluency in German and English are mandatory
What Takeda can offer you:
A competitive remuneration package with a minimum salary of € 3.307,50 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
Work @ home depending on the position / department
Comprehensive training programs
In-house job rotation program
In-house Canteen with discounts or meal vouchers
Works council (events, festivals, shopping vouchers, etc.)
Employee Referral Program
Employee Recognition Program
Takeda Resource Groups
Medical checkups
Free vaccination program
Fitness Center
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
