HireDiversity

Eure, FR

EMEA Quality&Compliance Staff Engineer-000009K6

Description

The EAME External Manufactures Quality & Compliance group oversights the External manufacturers that manufacture a range of products ranging from Cosmetics, Medical Devices and OTC drugs. The position will be in charge of managing European portfolio of External manufactures against Regulatory requirement and J&J policies, standards and procedures

KEY RESPONSABILITIES :
- Quality & Compliance management of External Manufacturers manufacturing OTC products for J&J Consumer EAME, according to regulatory requirements and J&J sector and enterprise policies and procedures.
- To carry out the ongoing GMP quality audits and provide technical support
- Approve new EMs and their laboratories.
- Manage quality issues resolution and communication
- Proactively identify quality and compliance gaps in the portfolio of EM sites and ensure continuous improvement process of the External Manufacturers through KPI and Management Action Plan and CAPA follow up.
- Follow-up on the implementation of the different QA projects/new WWSP (Worldwide Standard Procedures) at the sites
- build partnership with Supply Chain, R&D, Regulatory as well as other relevant stakeholders.

Qualifications

- Scientific master degree (Pharmacy, Chemistry, Engineering)
- In depth knowledge of GMP acquired through minimum 5 years experience in Manufacturing, Quality Assurance, Quality Control, Validation or Engineering in international pharmaceutical product manufacturers.
- Strong knowledge of sterile conditions/requirements/environment
- Knowledge of European Legislation for Marketing Authorizations and variations
Fluent English and French

Primary Location:Europe/Middle East/Africa-France-Haute-Normandie-Eure
Organization: Johnson & Johnson Santé Beauté France SAS (7101)
Job Function: Quality Assurance