Regulatory Cmc Senior Lcm - Suresnes, France - KELLY OCG

KELLY OCG

Entreprise vérifiée

Suresnes, France

il y a 1 semaine

Posté par:

Sophie Dupont

beBee Recruiter

Description

KELLY OCG is an intellectual services company dedicated to the health industries.

Our scientific experts accompany our clients in their projects, throughout a drug development or health product and its evaluation.

Your main missions will be to:

1.
Regulatory CMC documentation
Ø Contribute in close contact with pharmaceutical expert to the preparation of the Quality Overall Summary (QOS)

2.
Pharmaceutical Responsibilities
Ø Participate to transverse project teams for pharmaceutical and industrial development: management of Out of Specification (OOS for production batches on stability), Product Quality Review (PQR), follow up of CMC commitments for the product under his/her responsibility

Your Profile:

Ø Pharmacist or science graduate

Ø Good knowledge of Guidelines (ICH, EU etc, Eurasian guidelines would be good)

Ø Proactive, autonomous

Type d'emploi :
Temps plein, CDD
Durée du contrat : 6 mois

Salaire : 45 000,00€ à 55 000,00€ par an

Avantages: