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　　Job Description

　　Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a

　　Compliance Specialist (f/m/ d)

　　In this role, you will support our international Compliance Department, significantly contributing to the adherence and future assurance of GMP compliance at the Singen site. Moreover, you will actively engage various projects, e.g. in Dengue Vaccine projects, providing you with the opportunity to participate in groundbreaking vaccine development initiatives and make a substantial contribution to global health.

　　Your main responsibilities:

　　Coordinate local guideline compliance / gap assessment process, including maintaining process SOP in alignment with the latest regulatory guidance, industry requirements and Takeda's global SOPs.

　　Track and manage corrective and preventive actions (CAPAs) resulting from gap assessments.

　　Management and maintenance of SISR (Site Inspection Success Register) for Singen (quarterly updating)..

　　Perform gap assessments for inspection and audit findings at other Takeda sites.

　　Assist in the management, coordination, and performance of Health Authority Inspections, Customer Audits, and Internal Quality Audits.

　　Support activities related to inspection readiness, such as IRE (Inspection Readiness Exercise) and walkthroughs.

　　Contribute to the self-inspection process by performing self-inspections as a Lead Auditor, representing process owners, and tracking and closing corrective measures.

　　Maintenance of Compliance Documentation e.g. Site Master File, Quality Manual as well as preparing and review of SOPs relevant for the Compliance Department.

　　Your profile:

　　University degree in natural sciences or a related field.

　　You have gained first experience in the pharmaceutical industry including Quality unit experience.

　　With a broad overview of all relevant national and international pharmaceutical directives, guidelines and knowledge of their requirements you can support us in various projects at the Singen site.

　　You are familiar with the use of MS Office tools and can demonstrate proficiency with electronic quality management systems.

　　Effective communication and consistently delivering on commitments.

　　Proficiency in both English and German is essential, with a particular emphasis on written German skills.

　　In this position you will report to the Inspection Management Quality Compliance.

　　Your benefits :

　　Attractive and competitive salaryaccording to collective bargaining agreement

　　Open-minded and modern working environment

　　Hybrid working model

　　30 vacation days

　　Company pension plan

　　Further education and training

　　Travel allowance

　　Subsidized canteen

　　Subsidized sports programs

　　Disability insurance

　　Supplementary nursing care insurance

　　Long-term account

　　Employee discounts

　　Employee Stock Purchase Plan

　　Employee Referral Program

　　Deferred compensation as desired

　　Future amount (addition only for tariff positions)

　　Global Wellbeing Program

　　Childcare

　　Employee Recognition Program

　　About Us:

　　Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

　　In Singen around 1,000 employees specialize in the production of liquid, semi-solid and freeze-dried pharmaceuticals. In November 2019, we inaugurated our first dengue vaccine factory worldwide here. Singen is located at the beautiful Lake Constance in Baden-Württemberg.

　　How we will support you :

　　Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, 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. If you are living with disabilities, chronic illness or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.

　　Locations

　　Singen, Germany

　　Worker Type

　　Employee

　　Worker Sub-Type

　　Regular

　　Time Type

　　Full time