Regulatory Cmc Senior Lcm

il y a 4 jours

Suresnes, France KELLY OCG Temps plein

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:

- Participation au transport
- RTT
- Titre-restaurant

Programmation:

- Du lundi au vendredi
- Périodes de travail de 8 heures
- Repos le week-end
- Travail en journée

Expérience:

- industrie pharmaceutique: 4 ans (Exigé)
- Documentation AR CMC: 2 ans (Exigé)

Lieu du poste : Télétravail hybride (92150 Suresnes)

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