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Quality Assurance Manager MCO EE

応募 後で応募 求人ID R0013172 掲載日 10/10/2019 Location:Budapest, Hungary; Belgrade, Serbia; Bucharest, Romania; Ljubljana, Slovenia; Riga, Latvia; Sarajevo, Bosnia and Herzegovina; Sofia, Bulgaria; Vilnius, Lithuania; Zagreb, Croatia; Tallinn, Estonia

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Job Description

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers, encourage innovation, and strive for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliverBetter Health and a Brighter Futureto people around the world.

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career?

If so, be empowered to take charge of your future at Takeda. Join us as a Quality Affairs Manager for the multi-country organization of Eastern Europe (MCO EE).

Accountabilities

Leadership:

  • Work closely with RA/QA/PV Head MCO EE to develop and maintain MCO/LOC quality governance
  • Support onboarding, training, and knowledge transfer together with Regional RA/QA/PV Head within the MCO Eastern Europe RA/QA/PV providing an upskilling on negotiations and networking
  • Ambassador for Corporate Philosophy and Takeda-ism

​Quality Assurance

  • Coordinate the implementation of Global PDD Standards and Standard Operating procedures (SOPs) that are aligned with local requirements
  • Develop and maintain GxP related controlled documents in the MCO EE Quality Management System and coordinate development and maintenance of GxP related controlled documents in the individual LOCs Quality Management Systems, act as regional business system administrator in LEADs.
  • Ensures that MCO and LOC Quality Management System (QMS) is implemented at each individual LOC and aligned with the needs of the organization, perform gap analysis for MCO/LOC GxP SOP’s vs. Global and prepare a suggestion for changes.
  • Manage Gap assessment forms and ensure timely implementation of required changes
  • Maintain Training matrixes and coordinate training assignments in LEADs and update them as it is required create monthly compliance reports for LOC QA.
  • Support GDP operation in counties where Takeda owns WDL
  • Support change control and preparation of local application
  • Take over L-Shire QA activities until full integration:
    • Selling Authorization  (L-BXLT)
    • Temperature Deviation (L-BXLT) management
    • Handling complaints and customer inquiries in accordance with SOP
  • Plan and support self-assessments/audits of the MCO/GxP vendors to monitor compliance with applicable procedures and requirement
  • Manage inspections/audits of Takeda suppliers
  • Ensure audit/inspection readiness of MCO/LOC
  • Get trained and act as a lead auditor for Takeda suppliers/GxP vendors
  • Manage MCO EE quality issues (complaints, recalls, deviations, CAPAs) effectively
  • Collating individual LOCs’ Monthly Quality Council reports into the MCO EE Monthly Quality Report
  • Maintain oversight of quality agreements

Area covered: MCO Eastern Europe (Hungary, Romania, Bulgaria, Serbia, Croatia, Slovenia, Bosnia & Herzegovina, Estonia, Latvia, Lithuania, Albania, North Macedonia, Montenegro)

Locations

Budapest, Hungary

Belgrade, Serbia, Bucharest, Romania, Ljubljana, Slovenia, Riga, Latvia, Sarajevo, Bosnia & Herzegovina, Sofia, Bulgaria, Tallinn, Estonia, Vilnus, Lithuanuia, Zagreb, Croatia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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