Compliance Specialist Pharma (all Genders)

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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 Pharma (all genders)
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 salary according 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