Johnson & Johnson Careers

Computerized Quality Systems Specialist

Leiden, Netherlands
Quality Systems


Job Description

Requisition ID: 1905710859W

The Business Information Specialist acts as an intermediate between the user groups, the Quality Organization and local and global IT and Quality Systems organizations to effectively develop and maintain Quality computerized systems. Functions as a Super User Leader for the JBV site.
 
1
Advises the Business Owner regarding IT applications solutions fitting the long term strategies for specific -Quality computerized systems. Supports in the development and implementation of a long term strategy for specific systems in a co-operation with the Quality Business Owners and local and global IT and Quality Systems departments. Creates overview of Quality computerized systems and supported processes.
 
2
Identifies and specifies improvements in processes and related Quality computerized systems, in close co-operation with (Super) Users, Quality Business Owners and the IT System Owner(s).
 
3
Is responsible for the validation of specific cGMP related Quality computerized systems. Ensures that the validated state of cGMP Quality computerized systems is maintained.
 
4
Functions as a Super User Leader for specific Quality computerized systems.
 
5
Represents the site in the Global Quality Organization for the development and implementation of specific worldwide quality systems.
 
6
Contributes to the development and ensures enforcement of standards and procedures for Quality computerized systems.
 
7
Leads or participates in implementation projects of Quality computerized systems (worldwide and local). Liaises with and co-ordinates several parties, including external vendors.
 
8
Ensures that training for the Quality Systems under his/her control is adequate and rolled out.
 
9
Is responsible for performance reporting to management (e.g metrics).
 
 
 

MAGNITUDE & COMPLEXITY

 
The focus in the position is on the responsibility for computerized Quality Systems. These systems have to meet the requirements and needs of the users and need to be technically feasible, for which a close working relation needs to be established with the IT and Quality Systems departments, Business owners and users. The area of work is complex and the systems are of vital importance to the Quality group and JBV as a whole.
 
The uniqueness of the position is determined by the functional insight in the processes of the business combined with knowledge of automated systems. Specializations necessary are understanding of IT Systems, data-acquisition and process-control and a thorough understanding of the procedural requirements for the pharmaceutical industry.
 
The position requires excellent communication and good project leader skills. Independent thinking and decision-making is a must. The Business-Information Specialist is self-driven and keeps up to date on new developments in his/her area of expertise. The Business-Information Specialist will have to be able to give direction and set priorities in co-operation with users, IT and other departments involved.
 
It is the jobholder’s responsibility to observe the necessary caution and carefulness in order to avoid dangers for the safety or health of themselves or others and for the environment, when carrying out activities. This implies e.g. that machines, apparatus, tools, dangerous compounds, transportation means and other expedients must be used properly, when necessary with use of the prescribed protective means.
The jobholder shall not change or remove installed safe guards and will use them in a safe way. He immediately acknowledges management of dangers for the safety, industrial hygiene and the environment. Furthermore the jobholder should adhere to all safety, industrial hygiene and environmental procedures.
 

Qualifications
Qualifications:
 
1
  • Minimum education required for Business Information Specialist: Minimally a Bachelor in Business Administration or Information Management, or equivalent.
 
2
 
 
 
 
 
 
 
 
 
 
Minimum experience required for Business Information Specialist:
  • Minimum of 3 years of experience with business information of control systems, preferably in a cGMP or otherwise regulated environment
  • General knowledge of IT solutions and available Quality computerized systems
  • Knowledge of Quality processes in a pharmaceutical environment
  • Experienced in process analysis and improvement
  • Experienced in Business – IT alignment
  • Is able to work in an international environment
  • Excellent communication skills, fluent in English

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Biologics (7266)
Job Function
Quality Systems
Requisition ID
1905710859W