At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Essential Job Duties and Responsibilities
The Commercial Quality function is responsible for GxP Quality Compliance at JJ (Janssen Cilag GmbH) Germany to further develop, maintain and ensure compliance of the JJ Germany QMS (Quality Management System) in accordance with all relevant JJ standards and external guidelines and laws.
The (Experienced) Analyst Commercial Quality might be involved in the following QMS elements/processes after adequate training:
• Product Quality
o Complaint handling: Communication with customers and pharmacies, intake of Product Quality Complaints (PQC), field sample evaluation, review of investigation results, and statistical analysis of received PQCs
o Coordination with internal stakeholders such as Product Quality Vigilance (PQV)/local Pharmacovigilance (PV) and reconciliation
o Product launches, divestitures, and delistings
o Review of parallel imports
• Quality Management Responsibilities:
o Audit and inspection management
o Quality System Management Review
o Change management
o Document management
o Non-conformance (event/deviation/CAPA) management
o Training management: ensuring training of GxP functions
o Supplier management
o Product Quality Review (PQR)
o Creation and update of inter-company quality agreements
• Ensure overall Good Distribution Practices (GDP):
o Handling of distribution-related customer complaints (delivery service issues
o Version management: batch release/blocking and control of packaging materials in SAP
o Repackaging and relabeling activities for Markets of local operating company
o Third-Party Logistics (3PL) management (including narcotics distribution centers and transportation suppliers)
• Collaboration in international projects as subject matter expert for specific CQ processes
At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Essential Job Duties and Responsibilities
The Commercial Quality function is responsible for GxP Quality Compliance at JJ (Janssen Cilag GmbH) Germany to further develop, maintain and ensure compliance of the JJ Germany QMS (Quality Management System) in accordance with all relevant JJ standards and external guidelines and laws.
The (Experienced) Analyst Commercial Quality might be involved in the following QMS elements/processes after adequate training:
• Product Quality
o Complaint handling: Communication with customers and pharmacies, intake of Product Quality Complaints (PQC), field sample evaluation, review of investigation results, and statistical analysis of received PQCs
o Coordination with internal stakeholders such as Product Quality Vigilance (PQV)/local Pharmacovigilance (PV) and reconciliation
o Product launches, divestitures, and delistings
o Review of parallel imports
• Quality Management Responsibilities:
o Audit and inspection management
o Quality System Management Review
o Change management
o Document management
o Non-conformance (event/deviation/CAPA) management
o Training management: ensuring training of GxP functions
o Supplier management
o Product Quality Review (PQR)
o Creation and update of inter-company quality agreements
• Ensure overall Good Distribution Practices (GDP):
o Handling of distribution-related customer complaints (delivery service issues
o Version management: batch release/blocking and control of packaging materials in SAP
o Repackaging and relabeling activities for Markets of local operating company
o Third-Party Logistics (3PL) management (including narcotics distribution centers and transportation suppliers)
• Collaboration in international projects as subject matter expert for specific CQ processes
Minimum Qualification
• University degree in Pharmacy / “Approbation als Apotheker:in”
• Works Experience as a pharm trainee for Analyst role or for Experienced Analyst Role: Minimum 2 years workexperience as Pharmacists
• Excellent verbal and written communication skills in German and English, including ability to effectively communicate with internal and external customers.
• Very good computer proficiency e.g., MS Office, QM IT tools like COMET, TrackWise, Summit, TruVault, ICD, PQMS, SAP EUROPE 2.
Other Requirements
• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
• Excellent organizational skills to set priorities and structure own area of responsibility efficiently.
• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
• Willingness to take initiative and work independently. Proactively identifies and responds to problems and opportunities.
• Can take calculated risks and has the courage to learn from experience.
• Has resilience to achieve qualitatively consistent results even in stressful situations. Shows flexibility through adaptability to changing requirements. Works with conscientiousness and accuracy.
• Excellent communication skills, performs active listening, empathizes with others, and responds appropriately.
• Shows integrity and a credo-based approach, builds trust.
• Shows results and performance orientation and takes personal responsibility for achieving business goals and developing solutions; consistently delivers results that meet or exceed expectations; puts the patient / customer at the center of all considerations; focuses on creating additional value for the patient / customer.
Diversity, Equity Inclusion at Johnson Johnson means "YOU belong"
For more than 130 years, diversity, equity inclusion have been part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential. No matter who they are.
Minimum Qualification
• University degree in Pharmacy / “Approbation als Apotheker:in”
• Works Experience as a pharm trainee for Analyst role or for Experienced Analyst Role: Minimum 2 years workexperience as Pharmacists
• Excellent verbal and written communication skills in German and English, including ability to effectively communicate with internal and external customers.
• Very good computer proficiency e.g., MS Office, QM IT tools like COMET, TrackWise, Summit, TruVault, ICD, PQMS, SAP EUROPE 2.
Other Requirements
• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
• Excellent organizational skills to set priorities and structure own area of responsibility efficiently.
• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
• Willingness to take initiative and work independently. Proactively identifies and responds to problems and opportunities.
• Can take calculated risks and has the courage to learn from experience.
• Has resilience to achieve qualitatively consistent results even in stressful situations. Shows flexibility through adaptability to changing requirements. Works with conscientiousness and accuracy.
• Excellent communication skills, performs active listening, empathizes with others, and responds appropriately.
• Shows integrity and a credo-based approach, builds trust.
• Shows results and performance orientation and takes personal responsibility for achieving business goals and developing solutions; consistently delivers results that meet or exceed expectations; puts the patient / customer at the center of all considerations; focuses on creating additional value for the patient / customer.
Diversity, Equity Inclusion at Johnson Johnson means "YOU belong"
For more than 130 years, diversity, equity inclusion have been part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential. No matter who they are.