Johnson & Johnson Careers
Senior Quality Assurance Associate, CLS Q&C HUSE
Requisition ID: 1805676308W
Janssen, part of Johnson & Johnson Family of Companies, is now looking for an experienced Head of Finance.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
The position is accountable for the oversight and execution of a Facility and Quality Management Systems remediation program at partner facility (3PL) in Hungary and SEE, with limited involvement in other CLS 3PL location within the CEE cluster that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors.
The position serves as a single point of contact between the 3PL facility and the corresponding CLS cluster operational and Quality leads on Distribution Quality related matters (e.g. NC/CAPA, Customer Complaints).
You will have the following areas of responsibility:
Distribution and Inventory Management Processes:
• Responsible for the execution of Quality Management System and Compliance elements such as documentation, record, metrics and KPIs, dashboard, training, audit schedule and follow-up
• Responsible for the quality oversight of all product quality
Special Processes (Product Testing, Repack-Relabel, Temp. Control & Monitoring)
• Accountable for ensuring requirements for physical product testing (e.g. functional testing, visual inspection & verification) occurring in the DCs.
• Responsible for ensuring appropriate Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC
• Accountable for ensuring adherence to temperature control and monitoring requirements within the facilities.
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 overseeing the controls and quality standards for Quality systems validation, including WMS, CAPA, NC, Internal Audits, Doc mgmt software systems
• Responsible for ensuring management of Management Reviews of the DCs.
• Accountable for the successful management of all Health Authority inspections conducted.
• Responsible for the proactive identification and mitigation of compliance risk at the DCs through internal audits.
Qualifications and experience of the successful candidate:
• 5+ years in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business
• University level education Chemistry/Pharmacy/Microbiology/Medicine
• Knowledge of GMP and GDP preferred; Experience as an internal auditor / lead auditor is an asset
• Change management and project management experience is an advantage
• Knowledge of quality and regulatory compliance in delivery to customer and health authority
• Compliance experience, QMS, DC Q&C management experience
• Strong presentation skills, collaborative approach, analytical skills, attention to detail
• Fluent in Hungarian & English
• Ready for travel within Hungary and SEE (50%)
What do we offer:
• Interesting job in a prestigious international healthcare company
• Highly professional environment and highly competitive innovative product portfolio
• Friendly and supportive team members and management
• Opportunities for professional growth and career development
• Possibilities to take part in different projects
• Motivating financial remuneration and nonfinancial benefits
Janssen-Cilag Kft. (8396)