Johnson & Johnson is an American multinationalcompany founded in 1886 a world leader in the development of products and devices for surgical therapies and pharmaceutical companies, as well as in the marketing of consumer products for personal hygiene, and is organized into three business segments : Pharmaceutical, Medical, Consumer.
For Johnson & Johnson Medical Italy, we are looking for a QA Specialist to be hired with a Fixed-Term contract (1 year) in the Customer Logistics Services Quality and Compliance function (CLS).
The CLS Quality & Compliance is accountable for the oversight and execution of Quality Management Systems and compliance at CLS Distribution Center location (internal and / or 3PL) within the corresponding country that receive, pick, pack, store, inspect, repack / relabel and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors
The Quality Specialist will support CLS country operational team on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues, sustaining Quality management system in Italy Customer Services, Distribution Centers (DC) and supervision of Suppliers (3PLs) of warehousing & transportation in accordance to applicable local regulations and J&J requirements.
He / she will also have the responsibility for ensuring that quality system and processes are implemented and maintained accorder to Business Quality Manual.
Essential duties and responsibilities
Quality Management Systems
Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of Quality related issues.
Responsible for management of Quality systems, including CAPA process and systems, document management, change control, training management, preventative maintenance systems, Quality agreements, other.
Responsible for the successful management of all Health Authority inspections (e.g., FDA, MHRA, etc.) as well as other logistics and transportation related inspections (e.
g., TSA, DEA, etc.) conducted.
Responsible for the proactive identification and mitigation of compliance risk at the DCs through QScan, internal audits, and other compliance programs and for the management of facility licenses
Distribution and Inventory Management Processes
Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations, overseeing the controls and quality standards for all distribution and inventory management activities (e.
g. receiving, pick, pack, lot reconciliation).
Special Processes (Product Testing, Repack-Relabel, Temp. Control & Monitoring)
Responsible for implementing requirements for repackaging and relabeling, over labeling, kitting, and reworking operations to be conducted within the Distribution Center and collaborate with business partners to meet pre-defined requirements.
Responsible for validation of temperature controlled (cold chain and controlled ambient) facilities with support and directions from the Sr.
Manager Transportation and Temperature Control Q&C, CLS Q&C EMEA.
Requirements / Skills and Qualifications :
Bachelor’s or Master’s degree in either life science discipline, e.g. Chemistry, Pharmacy, Biology or Engineering.
Minimum 1 years of experience in one of the following business sectors : Pharmaceutical, Medical Device, Consumer.
Experience in Quality or Manufacturing departments is preferred.
Excellent influencing and interpersonal skills (communication and listening skills) as well as teaming with different stakeholders.
Able to work virtually connecting with other sites, customers and global functions.
Ability to influence and interact at multiple levels of the organization.
Strong ability to manage problems and urgencies during issue management.
Ability to manage multiple priorities and deliver excellent results.
Fluency in English and Italian is required.
The resource will be based in Milan Italy.