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Chemistry, Manufacturing & Controls (CMC) Scientist – Pre Approval από την εταιρεία PharOS Ltd

5 ημέρες για να κάνετε αίτηση
Πλήρης Απασχόληση
Αθήνα

Περιγραφή Θέσης

About PharOS
Developing Value, Supplying Success

Founded in Athens in 2002, PharOS is a privately owned pharmaceutical Company, developing and supplying generics value added products with a global portfolio. Our expertise covers all aspects of product development from API sourcing up to market release.  We provide a broad portfolio of products and intellectual property to leading pharmaceutical companies.

At PharOS, we have a high skilled workforce of more than 85 professionals. Biologists, Chemists, Pharmacists, scientists all focused on developing and placing in the market top quality generic and other value added pharmaceuticals that improve the lives of patients to more than 86 countries. Our people are our core competitive advantage that helps us being one of the fastest growing pharmaceutical development companies in Europe.

For PharOS our customers, are our partners! Our aim is to extend the lifecycle of the product, as our people are able to provide an exceptional level of customer service and support, based on their expertise and professionalism.

PharOS is expanding its product pipeline and is currently recruiting, for CMC Scientist within the Chemistry Manufacturing & Controls department based in company’s Headquarters in Athens, Greece.

We are seeking for

                          Chemistry, Manufacturing & Controls (CMC) Scientist – Pre Approval 

Role Description 
  • Create and review product CMC relevant documentation in line with EMA and ICH guidelines intended for dossier compilation of Modules 2-5.
  • Review, edit and create e-CTD CMC regulatory submissions. 
  • Compilation and monitoring of the progress of scientific responses to deficiencies raised by the regulatory agencies.
  • Compilation of additional comparative in-vitro study reports for non-EU submissions and dossier customization as per client needs.
  • Maintenance of GAP analysis until first dossier approval. 
  • Record commitments made during registration. 
  • Complete pre-audit checklists, organize on-line dossier audits and compile responses to clients’ audit comments for Modules 2-5, after the first dossier submission. 
  • Overall customer support for any CMC queries received.


Experience & Qualification

The ideal candidate should have:
  • Education to a post-graduate degree level in Pharmacy, Pharmacology, Chemistry, Biology or similar scientific disciplines.
  • At least 2 years’ experience in CMC or Regulatory.
  • Knowledge of ICH and EMA guidelines related to CMC. 
  • Knowledge of pharmaceutical technology related to oral solid dosage forms, oral solutions and injectable presentations.
  • Excellent English oral communication and scientific writing skills.
  • Very good organizational and project management skills.
  • Oriented to focus on detail.
  • Communicate effectively both internally and externally.

PharOS Ltd Offers
  • Competitive salary
  • Healthcare package
  • Continuous training on all aspects of CMC 
  • Challenging working environment

Κωδικός αναφοράς

CMC) Scientist – Pre Approval

Όμοιες Θέσεις

REGULATORY AFFAIRS OFFICER Πικέρμι ELPEN Α.Ε.
Formulation Development Scientist Αθήνα PharOS Ltd
Quality Assurance Officer Αθήνα Cana A.E.
Υπεύθυνος/η Διασφάλισης Ποιότητας Αθήνα Ανώνυμη Εταιρία
Χημικός ή Βιολόγος Αθήνα MEDICON HELLAS AE
Υπεύθυνος-η για το Τμήμα Διασφάλισης Ποιότητας Οινόφυτα Εταιρία Παραγωγής & Εμπορίας Καταναλωτικών Ειδών
Χημικός Μηχανικός Αθήνα Ανώνυμη Εταιρία

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