Compliance scientist - Pharma

Settore: / Legale /
Azienda: Randstad Italia Spa
Data annuncio: 21/06/2023
Sede di lavoro: Roma

Functieomschrijving



For an important company in the pharmaceutical sector, Randstad Italia is looking for an:


 


Compliance scientist Pharmacopoeia



Responsabilità



The “Global Analytical and Pharmaceutical Scientific Innovation” Department / “Analytical Regulatory and CMC Science” Unit is providing Regulatory support and coordination on analytical topics including improvement in pharmacopoeial compliance.


It is also proactively monitoring new analytical requirements by Regulatory Authorities and cross check discrepancies among different pharmacopoeial requirements, ensuring that methods, technologies, and validation are compliant/aligned to latest regulatory expectation. 


The candidate will support these activities in both physico-chemical and biological field analytical methods for QC purpose (development, validation and in routine activity) for both early Phase, late Phase, and marketed products.


In particular, the candidate will have the following responsibilities:


- Drafting and review of reports on Pharmacopoeial comparability 


- Identify and communicate implications for analytics of pharmacopoeial updates


 



Functie-eisen



Professional background experience:


  • Degree in Life Science is required (Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Chemistry, or equivalent)

  • 1-3 years of experience in analytical development and validation.

  • A master or experience in regulatory requirements is a plus

  • Problem solving skills 

  • Excellent skills in writing, oral, interpersonal communication, and presentation (English)

  • Good communication skills



We offer a temporary contract full time


 


Work area: Roma Est




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