Compliance Specialist Pharma - Singen (Hohentwiel), Deutschland - ARIAD

ARIAD
ARIAD
Geprüftes Unternehmen
Singen (Hohentwiel), Deutschland

vor 1 Woche

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization.

It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network.

When you're a part of our team, you'll do meaningful work that makes an impact on the lives of patients.

Learn more about us and explore the opportunities to build a remarkable career.


Job ID R0114542
Date posted 02/08/2024
Location Singen (Hohentwiel), Baden-WürttembergAre 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 selfinspection process by performing selfinspections 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
  • Openminded 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
  • Longterm 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 Singenaround 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. Singenis located at the beautiful Lake Constance in Baden-Württemberg.


How we will support you**:


Locations:
Singen, Germany

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Worker Type: Employee

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Worker Sub-Type: Regular

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Time Type: Full time
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