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Quality Assurance / CSV (M / F) - REF MS

Pharmaceutical

Localisation : Canton de Vaud

CDI

Start : ASAP
Experience : 5 to 10 years of experience
Salary : depends on experience

Postuler

Role

 We are looking for an experienced CSV professional to join our Business Unit Life Science

 

Responsibilities

The Validation Consultant will provide CSV consultancy support to our clients in GxP environments (GMP & GLP). You ensure Computer Systems validation and documentation, in accordance to GMP requirements:

 

  • Manage activities linked to CSV
  • Draft Computer Systems requirements (URS)
  • Define the Validation Plan and test plans
  • Conduct the risk Analysis
  • Define the Traceability Matrix
  • Draft & execute the qualification tests (DQ, IQ, OQ, PQ)
  • Manage and capitalize on suppliers tests (FAT, SAT)
  • Draft final validation reports

Required Skills 

  •  Experience required 5 years in similar position, good knowledge of Pharmaceuticals or Biotechs environments.
  • Experience in MedTech is an asset
  • Bachelor or Master degree in automation, engineering, IT, sciences or equivalent by experience
  • Expert knowledge of international GxP drug development regulations, as well as GAMP 5 and 21 CFR. ISO 13485 and IEC 62 304 is a plus
  • Strong leadership, open minded and professional communication skills
  • Highly self-motivated, well organized, confident, possessing a solution oriented mindset and able to develop innovative solutions to issues
  • Ability to Project Management, interdisciplinary team management
  • Written communication skills, including experience in making presentations, meetings, and training sessions

 

Languages

  •                                 Bi-lingual in French
  •                                 Fluency in English (written and spoken)

 

You have a European or Swiss nationality or a valid Swiss work permit.

If this seems to be your next challenge, do not hesitate to contact me: maria.sawan@fortil.ch / +41 78 229 70 01 / LinkedIn.

If you think this opportunity might interest somebody you know, feel free to transfer him or her the offer.

Maria SAWAN

Contacter

Talent Acquisition Recruiter Maria SAWAN

FORTIL Switzerland

FORTIL se développe et ouvre sa première agence internationale située à Genève composée de son équipe Suisse.

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