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CSV Expert - Quality Systems Department

Łyszkowice, Poland

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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CSV Expert - Quality Systems Department

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Job ID R0008934 Date posted 05/23/2019 Location Łyszkowice, Poland

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Job Description

Are you looking for a patient-focused 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 CSV Expert in Quality Systems Department in our Manufacturing Plant, Łyszkowice. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.

Job purpose:

Computerized Systems Quality Expert helps deliver on Takeda’s commitments for patient safety, product quality and data integrity by ensuring the quality and regulatory compliance of computerized systems and regulated data.

This is accomplished by providing independent oversight of computerized system validation and operational activities to confirm that computerized systems and regulated data are maintained in compliance with applicable Healthcare laws and regulations, and Takeda policies and procedures. The Quality Expert also drives and sustains improvements to computerized systems and the processes for implementing and supporting them. 

Key Responsibilities:

  • Ensuring the quality and regulatory compliance of computerized systems
  • Ensuring compliance of the manufacturing site with data integrity (DI) best practices and controls
  • Lead on-going initiatives and improvement projects in areas related to computerized systems and data integrity
  • Development of local CSV and DI QA related procedures based on global SOPs
  • Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards.
  • Identify and report any quality or compliance concerns, risk and issues and take immediate corrective action as required in the area of CSV and DI
  • Promote and champion quality and best practice oriented culture regarding computerized systems.
  • Authorize validation deliverables, maintenance procedures  produced for local computerized systems
  • Conduct audits of computerized system vendors and 3rd party software providers
  • Provide expertise and support during audits and inspections of Takeda
  • Proactively identify, share & train emerging industry standards/trends within the site in the area of computerized systems and data integrity

Qualifications:

  • Master degree in Science, Business, Engineering, IT or related discipline or 5 years equivalent professional experience.
  • Minimum 5 years experience with ICH, EMA and/or other international healthcare regulatory requirements.
  • Minimum 3 years experience working with GxP computerized systems in production, QC laboratories and / or IT
  • Experience making quality assurance and compliance decisions in regards to software development, validation and support.
  • Experience with all phases of software validation and infrastructure qualification.
  • Demonstrated multitasking project management and execution skills
  • Ability to influence & negotiate with teams from all levels of the organization and external suppliers.
  • Ability to read, analyze and interpret business plans, technical procedures, and government regulations
  • Proven analytical and problem resolution skills; ability to identify root cause of problems
  • Excellent verbal and written communication skills at the functional and technical level.
  • Proficient in Microsoft Office products
  • Advanced knowledge of English enabling working in international environment

Why Takeda:

  • Our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – guide how we work and can be felt across every department

  • We take actions and make decisions by focusing on patient-centricity; your contribution will make an impact on people’s lives and change futures every day

  • We take care about our employees and offer: interesting work in an international environment, the opportunity for self-development, stable employment conditions, benefit package (group insurance, private medical care, co-financing meals in the canteen)

Empowering Our People to Shine

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By engaging in our recruitment process you confirm you are aware and you accept Takeda Privacy Notice to Job Applicants. Data Controler is Takeda Pharma Sp. z o.o., Prosta 68, 00-838 Warszawa. You have a right to access your personal data, demand their rectification, erasure, removal, restriction of processing, data portability, as well as to lodge a complaint with a supervisory authority. You may request access to your data or to realize any of the abovementioned rights any time, to the extent specified by law – please contact us as it is described in the Privacy Notice

*LI-KS1-EUR

Locations

Lyszkowice, Poland

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

Job ID R0008934

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