Q&c Lead - Santa Palomba, Italia - Kenvue

Kenvue

Azienda verificata

Santa Palomba, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Q&C Lead W

Description

Johnson & Johnson New Planned Consumer Health Company, based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S Baby, BAND-AID, NEUTROGENA, TYLENOL, MOTRIN, and LISTERINE. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.

Q&C Lead, based in

any of our European sites
***
Role Summary:Provides Q&C leadership in the onboarding of new External Manufacturers (EM) in the portfolio of EMEA Source Q&C management, including pre-scouting, qualification, new product introduction (NPI) and post-launch monitoring of these EMs as well as the introduction of the new products linked to the new EMs.

Major Responsibilities:

Onboarding of new External Manufacturers (EM) & NPI:

Be involved in pre-scouting activities and support the decision process for new external partners
Execute initial GMP audits at selected EMs against the relevant guidelines (Eudralex, FDA 21CFR 210/211, ISO 13485, ISO 22716, ISO 9001)
Negotiate action plan with new EM and followupon completion
Negotiate the initial Quality Agreement with the new EM
Execute all necessary activities to add new EMs to the Kenvue Approved Supplier List
Be the first point of contact for the regional or global project teams managing the new products
Build relationship with the key stakeholders for the new EMs such as EM Make and Procurement
Support all activities related to new product introduction (NPI) such as process validation, cleaning validation, stability, product specifications
Preparation of FG specifications, marketed product stability protocols
Manage the postlaunch monitoring including managing quality issues, complaints and change controls
Introduce new EMs to Kenvue Quality Metrics and follow them up

EMEA Regional Program:

To take part in Regulatory Compliance initiatives at the EMEA regional level within the EMEA regional departments and at the assigned EM sites
To take part in or lead implementation of the different QA projects / new Kenvue standards at a regional and global level

Support to EMs Business & External Growth:

QA support in BCP / Reformulation / CIPs
Support in Supplier Reliability initiatives at new and existing EMs as agreed with line manager and Q&C Projects leader

Qualifications:

Job Knowledge Requirements:

Bachelor's Degree is required in Engineering, Pharmacy, Chemistry, Life Science, or related disciplines
At least 6 years experience in a GMP and/or ISO regulated industry (manufacturing/QA/QC)
EU, FDA and ISO regulations knowledge
Experience in MD would be a benefit
Auditing background is preferred
Strong communication, teamwork and problemsolving skills
Ability to work in a matrix organization
Fluent English and a second European language is desirable
Position includes international travels

Primary Location Europe/Middle East/Africa-Italy-Lazio-Pomezia (Santa Palomba)

Organization Johnson & Johnson S.p.
A.

Job Function Compliance