Johnson & Johnson Careers

Inspector, QC (Temp)

Madrid, Spain
Quality Control


Job Description

Requisition ID: 1805706173W

MISSION

 
Main responsibility of this position is to sustain Quality management system in Spain Customer Services, Distribution Centers (DC) and supervision of Suppliers (3PLs) of warehousing & transportation in accordance to applicable local regulations and J&J requirements.
 
Has the responsibility for ensuring that quality system and processes are implemented and maintained accorder to Business Quality Manual.
 
 

REPORT TO

 
Spain CLS Q&C Lead
 
Functional Group: CLS Q&C
 
Direct Reports: N/A
 
 

MAIN FUNCTIONS

 

Essential duties and responsibilities:

 
  • Built and sustain positive relantionships with the 3PL
     
  • Represent the company with health authorities in Product Quality activities when considered necessary by Quality Executive
     
  • Implement the Quality System via transposition of the requirements of the requirements of CLS Q&C. Establish required processes and procedures to comply with applicable local regulations and J&J requirements.  
     
  • To control actions related to Quality & Compliance at local 3PL, including warehousing, transportation & reverse logistics including returned goods inspection and items for destruction verification, mainly for Jannsen Cilag SA, guarantying product quality, identity and traceability throughout the supply chain, ensuring that GMP/GDP are fulfilled.
     
  • To control actions related to San Sebastian de los Reyes DC Quality Area (QACage) at local distribution center, specifically returned goods inspection and items for destruction verification.
     
  • To collaborate in the customer notifications related to Recalls and/or Field Safety Corrective Actions when required
     
  • Collaborate in the preparation of data for monitoring quality system performance versus local and J&J requirements via use of pertinent business and compliance metrics and goals, cooperating in the continuous improvement.
     
  • Coordinate the effective implementation with CLS Operations / CLS CS
     
  • Ensure Distribution Center/3PL Audit Readiness, in accordance to health authority requirements.
     
  • Accountable for the oversight and execution of Quality Management Systems and compliance at DCs and 3 PLs in Spain that receives, pick, pack, store, inspect, and deliver finished goods to end users.
     
  • Serves as a single point of contact to the corresponding CLS operational lead on Distribution Quality related matters and liaises with multiple Quality organizations to drive timely resolution of Quality related issues.
     
  • Revision of Janssen Cilag income lots & Consumer lots to be returned to stock from returns, prior to RP approval if applicable
     
  • Quality Auditor, if applicable
     
  • Notify the QE with any substantive concerns regarding product quality, safety and/or compliance, as per Escalation procedures.
  • Report al suspected adverse reactions, serious or non-serious, may be aware of within a maximun of 24 hours after being aware of it and communicate I to the Pharmacovigilance Department.
 
Special requirements:
 
  • As part of a cross sector organization, collaborate in any required cross sector CLS Q&C project or support to required areas
 
Other features of the job:
 
This role must maintain a close working relationship with local Commercial organization, with inclusion of specific Goals & Objectives related to current business priorities.
 

Qualifications

JOB PROFILE

 
Experience
  • Very valuable  1 or 2 years working experience in a quality role within an International Pharmaceutical/ Medical Devices Company.
  • Valuable 1 or 2 years working experience in a quality role or similar

 

 

Academic Training and Knowledge
  • Knowledge of ISO 9001 Standard or equivalent quality standards and J&J Quality & Compliance standards
  • Knowledge of Pharmaceutical /Medical Devises & Cosmetics regulations.
  • Audit Management experience (Health Authorities, Notified Bodies, J&J internal audits) and supplier audit.
  • Bachelors or Master degree in Pharma or Bioscience with relevant experience and background in Quality area.
  • User level knowledge of office IT and Excel
  • Qualificaton for internal audis
     
Essential requirements
  • Excellent written and oral local language and English communication skills
  • Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority
  • Strong collaboration skills and ability to build partnerships internally and externally
  • Ability to effectively present information to Management and public groups
  • Change management experience and influencing and interpersonal skills
  • Analytical skills with bifocal approach, being able of strategic approach keeping tactical and detailed focus.
  • Initiative and teamwork abilities
  • Confidentiality
  • Detail oriented
 
 
 

Primary Location
Spain-Community of Madrid-Madrid-
Organization
Johnson & Johnson, S.A. (8500)
Job Function
Quality Control
Requisition ID
1805706173W