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Qualified Person (m/w/d)

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Frankfurt am Main, Germany
Supply Chain/Logistics, English, German
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Job Description:

Job overview

Qualified Person, QP, in Quality Management Systems ("Sachkundige Person/Qualified Person according to §14/15 AMG")

Responsibilities
* Certification of drug batches as a knowledgeable person
* Solid understanding of regulatory requirements for commercial products
* Final evaluation and approval of deviations and complaints on a risk- based approach
* Auditing of manufacturing and testing facilities as well as performing self-inspections
* Participation in the supervision of customer audits and official inspections
* Evaluation and determination of meaningful CAPAS in agreement with concerned persons and tracking them
* Training of employees

Requirements
* Pharmacist with approbation as a pharmacist or comparable ("Sachkundige Person/Qualified Person according to §14/15 AMG")
* Suitability for designation as QP according to Medicinal Products Act §15 (1) and (4))
* Several years of professional experience in the GMP-regulated environment
* Profound understanding of aseptic filling (Annex 1) preferably with regard to biological products
* Experience in Data Integrity and Life Cycle Management desired
* Strong understanding of risk assessment and risk management fundamentals/tools
* Technical understanding of pharmaceutical processes
* Team and consensus builder, with definitive and authoritative decision-making ability
* Work experience in quality assurance as well as audit experience desired
* Assertive personality
* Flexibility and resilience
* Team Player
* Fluent German and English spoken and written

Our offer:
* An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
* An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
* An individual and well-structured introduction and training of new employees.
* You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
* As a globally successful and constantly growing company, Sanofi provides international career paths as well.
*
#LI-GSA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all

Source: Company website
Posted on: 08 Nov 2019
Job duration: 0 months
Languages: English, German
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