QA Pharma Complaint Specialist (m / w / d) / / Johnson &Johnson

Jobdescription

Caring for the world, one person at a time … inspires

and unite the people of Johnson & Johnson, we embrace research

and science- bringing innovative ideas, products and services to

advance the health and well-being of people.

High

quality is built into all manufacturing and quality processes, yet

still products are sometimes reported by our patients in a state

that is not in line with our expectations. To ensure continued

manufacturing process improvement and to address potential patients

risks Product Quality Investigations are led by QA Pharma

Complaints Specialists based on the feedback received from our

patients.

Main

responsibilities : Investigation of

product quality concerns based on customer complaints

Assessment, coordination and / or investigation of assigned

customer complaints

Inspection of returned

products, investigation of technical details, and root cause

analysis, risk assessment, and assist / lead associated CAPA

investigations

Ensurance of accurate

documentation and closure of each complaint in order to make and

document sound regulatory reporting

decisions

Development of a detailed

understanding of the products and previously investigated

complaints

Evaluation of market impact of new

complaints and escalation of critical issues for immediate

action

Review and analysis of complaint

information for trending / risk analysis and corrective actions and

resultant effectiveness of these

actions

Support of internal, external, and

third-party audits

Support of additional

project team activities and / or investigations, and participation in

process improvement projects

Qualifikationen

Who we are looking

for :

A Masters's Degree, PhD or

equivalent experience in engineering, physical, biological, natural

sciences is required

Investigative &

analytical critical thinking skills

Strong

decision-making skills ? able to make sound business decisions with

sometimes limited information

Strong written

and verbal communication skills in

English

Written and verbal communication skills

in German are of advantage

1 year of experience

in quality in a pharma / medical device or other regulated industry

is preferred but not required

Knowledge of

statistical applications and auditing practices is preferred but

not required

This

position is based in Schaffhausen, Switzerland and will initially

be limited to approx. 12 months. If you are interested in working

for a global leading health care company in a challenging role,

then send us your application in English today. Or give us a call

if you have any questions!