Manager External Supplier QA in Singen (Hohentwiel) bei Takeda Pharmaceutical

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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

Manager External Supplier QA (all genders)

Your main responsibilities:

• Supports cGMP activities for products in late phase clinical programs, launch and commercial manufacturing, conducted on behalf of the VBU including manufacturing, testing, packaging and shipment of all materials, to ensure compliance with Takeda QMS, cGMP and global regulatory requirements.

• Works as part of the Dengue QA Team with focus in Quality Assurance systems/process execution related to product specific late phase clinical programs and commercial activities, such as, but not limited to, batch disposition, document & data control, change control, investigations, inspection preparedness, life cycle management etc.

• Assures consistency in achieving product quality and compliance across multiple Contract Manufacturing Organizations (CMO)s and global markets.

• Responsible for day-to-day interactions with contract facilities like: CMOs, CTLs, and/or CSP
  

  • Conduct and support investigations into Good Manufacturing Practice related issues or problems associated with audits, batch records and complaints.
  • Review and approve manufacturing and testing deviations and investigations into out-of-specification results.
  • Supports timely execution and completeness of change management at interface with CMOs and of internal Takeda change management.
  • Review and approve batch production records and test records.
  • Review and approve validation documentations
  • Review and approve shipment or material transfer request
  • Perform interim batch assessment in preparation for QP batch disposition.

• To work with external manufacturing, project management, supply chain, technical operation, CMOs and QA to ensure timely closure of excursions to include deviations, CAPA, change controls and interim batch assessment as applicable.

Your profile:

• Bachelor’s Degree or higher in Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline.

• Minimum of 3 years of experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry(ies).

• Good Manufacturing Practice experience, or experience in other regulated industry.

• Excellent communication skills both oral and written.

• Experience with supporting product inspections from global Regulatory Authorities.

• Effectively represent Quality Assurance, both internally and externally.

• Experience in routine office software packages and specialized software applications as appropriate.

• Exhibit and promote Takeda Core Competencies

In this position you will report to the Lead, External Supplier QA.

Your benefits:

• Attractive and competitive salary
• Open-minded and modern working environment
• 30 vacation days
• Company pension plan
• Further education and training
• Travel allowance for public transport
• 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
• 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 opport