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September 22 2018  SpanishSpanish

    Detalles de Empleo

Empleo: Senior QC Scientist and Technical Lead (f/m):

La descripción del trabajo.:

Oferta de trabajo:
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   » Company:
Shire
   » Location:
Wien, Austria
   » Salary:
negotiable / month
   » Job type:
Full-Time
   » Posted:
6 mins ago
   » Category:
General

**Primary role**
+ QC oversight and effective management of Shire Contract test laboratories utilized from release and ongoing stability testing
+ Development of strategic short term and long term approaches to release and stability method performance and improvements, analytical support for process improvements, product comparability assessments
+ Interpretation of data trends for both release and stability, life cycle of methods and other technical support as required
+ Expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests and improvement initiatives
+ Lead investigator with strong understanding of compliance and cGMP?s, strong scientific judgment and leadership in decision making
+ Participate in cross functional teams to close investigations, determination of root cause and implementation of appropriate CAPAs
+ Create and presents trending and metrics reports on deviations and corrective actions
+ Lead management of the document change requests for method SOPs
+ Provide representation to tech transfer and CMC teams as needed, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations
+ Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
+ Support of validation activities for QC including authoring and/or reviewing protocols, coordinating testing with the functional area managers
+ Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies
**Requirements**
+ Experience of Technology Transfer of analytical methods
+ Ph.D. in Chemistry, Biology or other related fields with >5 years of relevant Postdoctoral/Industrial experience or M.S. with >7 years of relevant experience
+ Experience dealing with contract testing organizations is preferred
+ Team leadership
+ Good knowledge of statistical techniques in the use of problem solving data analysis
+ Ability to demonstrate standards of leadership – managing complexity/ innovations
+ Customer Focus Flexible Team Player Good influential skills
+ Regulatory filings and inspections
+ Strong knowledge of EU cGMPs and FDA guidelines
+ Experience with lean processes
+ Ability to work during routine business hours but be flexible to cover US and JP business hours on occasion
+ Ability to travel approx. 20%
+ Fluency in German and English
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. at https://youtu.be/ly_8oO-iJeU
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 ? 4.225,44 gross per month (full-time); increased payment is possible. We are looking forward to your application.
**_Notice to Employment / Recruitment Agents:_**
_Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire?s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration._
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
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Tipo de Empleo:
Sueldo: No especificado
Titulación: Sin especificar
Experiencia: No especificado
Localización del Empleo: Wien, Austria, otro
Tipo de empresa Empleador
Día de envío: 2018/08/14 / Viewed 1 times
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