2018-11-02 Assessing Vendor data for active and passive systems used in transportation and replenishment; Performing shipping qualification studies

Global Transportation Validation Expert (m/f)

Dienstort 1220 Wien Wien Unternehmen Shire
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Beschäftigungsart Vollzeit Position ohne Personalverantwortung Gehaltsangabe 3.163,33 € /brutto Jetzt online bewerben

Global Transportation Validation Expert (m/f)

Shire am 08.12.2018 in 1220 Wien

Global Transportation Validation Expert (m/f)

Job-ID: R0029351
Location: Austria - Wien - Benatzkygasse (Baxalta)
Category: Validation

In this position you will be part of the Shire Global Distribution Solution team and will be responsible for assuring that Shire products are transported under proper conditions and that shipping systems and processes are qualified in compliance with Shire Quality and Regulatory Agencies requirements. As a subject matter of GDP compliance on shipping systems and processes within Shire transportation and distribution network you will support multiple sites and CMOs. You will also be in charge of contributing to improvement of Shire baseline Supply Chain transport and distribution spend by continuously seeking opportunities to improve existing systems, processes and performance across Shire logistics network.

About the position in detail:

Perform shipping systems and processes qualification

  • Assessing Vendor data for active and passive systems used in transportation and replenishment
  • Performing shipping qualification studies considering holistic approach on global transportation and replenishment processes
  • Working with multiple Sites and CMOs, Supply Chain & Distribution Quality and logistics operations to ensure that Shire products are shipped with compliant and efficient solutions
  • Monitoring end-to-end performance of shipping solutions, perform trending analysis
  • Maintain validation master plans for Shipping systems and processes, perform change control activities and maintain database of qualified solutions

Support internal and external GMP audits related to shipping validation

  • Assuring that the regulatory status related to product transportation is well understood per facility prior to any regulatory audit
  • Defending shipping validation documents during audits as assigned
  • Support regulatory filings for new product launches

General responsibilities

  • Support evaluation and management of  temperature deviations in transportation and replenishment operations  and support continuous improvements
  • Develop and implement standards and SOPs for supporting the assessment, qualification, implementation, continuous improvement and lifecycle management of all distribution solutions
  • Act as a subject matter expert of GDP compliance on shipping systems and processes by managing through lifecycle, harmonizing and continuously improving quality and efficiency of Shire distribution solutions

Skills you need:

  • Education in engineering, chemistry, natural sciences and/ or a technical field
  • At least 2 - 4 years of experience in validation and/ or transportation/ logistics/ shipping, ideally in the pharmaceutical, chemical, food or a related industry
  • Fluent in spoken and written English language
  • German is beneficial, but not a must
  • Hands-on experience and exposure to technologies applicable to logistic validation and thermal packaging engineering validation
  • Proven knowledge and application of cGMP requirements
  • Demonstrated application of industry guidance/standards (ISTA, ASTM, ISPE, PDA, ISO, ICH, Pharmacopeias) and Regulatory CMC guidance documents
  • Experienced with multiple PM tools and processes
  • High level of MS office tools
  • Open-minded personality enjoying working in a multinational team
  • Travel up to 10% (Europe)

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees – our biggest asset – who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!

The minimum salary for this position is € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application!

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Global Transportation Validation Expert (m/f)

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