Complaint Vigilance, Analyst 3-00000O5F
Description
Position Summary
The Complaint Vigilance, Analyst 3 is expected to:
- Possess detailed knowledge of Janssen products and manufacturing sites to allow for independent triage of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Product Quality Management System. This may include but is not limited to, review of the event reported, determination of the defect category, criticality assessment, recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable
- Exhibit strong ability to collaborate and influence Business Partners (Internal JSC Manufacturing sites, External Business Partners, regional ESIQ organizations, Call Intake Centers, and Global Medical Safety/LSOs, Brand Protection, etc) to ensure appropriate complaint handling and improve complaint management processes.
- Develop and deliver appropriate training to complaint management system end users.
- Identify and implement complaint process efficiencies. This will include assessing the impact of proposed changes within and across functional areas that impacts the complaint handling process.
- Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects
COMPLAINT MANAGEMENT:
- Process and analyze product complaints according to Policies and Standard Operating Procedures.
- Evaluate product quality complaints for seriousness, correctness and consistency of categorization.
- Assign complaints to appropriate investigational sites.
- Communication of potential serious PQC’s in a timely manner, as appropriate.
- Retrieval of field samples (US only), as applicable.
- Ensure all relevant complaint data is obtained.
- Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc.) to gain knowledge of products and processes.
- Facilitate and participate within process of auditing Complaint Records to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making.
- Compile product and site-specific complaint trending data and complaint closure metrics as requested.
- Support internal and external audits and inspections.
- Participate within and/or facilitate special projects.
BUSINESS RELATIONS:
- Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, etc.) to continuously identify, assess, and improve complaint handling processes.
- Build consensus across functional areas
- Drive technical and process improvements. Influence change.
- Solicit customer feedback.
DOCUMENTATION:
- Create, revise and maintain applicable department WI’s and SOPs.
- Identify, assess, and implement process improvements to the standard process.
- Develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.
- Audit Complaint Records in PQMS to ensure standard process is being followed, and complaints are closed as required. Compile product and site-specific complaint trending data and complaint closure metrics as requested. Support internal and external audits and inspections.
EXTERNAL AND INTERNAL INTERACTIONS
- May interact with other J&J operating companies to harmonize complaint management processes and procedures.
- Interacts with product quality complaint handling, manufacturing and quality personnel at internal manufacturing sites across JSC and external partners.
- Interacts with safety and surveillance personnel at Global Medical Safety for investigation of adverse events with potential product quality issues.
- Provides support for internal audits and inspections by regulatory authorities.
- Analyzes data and other trends, and presents to management.
STEP-BE
Qualifications
Education:
- Bachelor Degree in Physical Sciences or Life Sciences, or equivalent experience is required; Master Degree can be an asset.
- Project management / PMP Certification is an asset.
Related experience:
- 4years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related or highly regulated industry.
- Relevant knowledge on root cause investigations (production, lab environment)
- Strong communication, organizational and project management skills.
- Prior demonstrated success at Analyst 2 level or equivalent.
Job Specific Competencies:
- Strong interdependent partnering skills, interpersonal communication, influencing skills.
- Can work independently in a global environment/virtual team
- Global mindset
- Ability to lead change initiatives, develop strong effective relationships with key resources and decision makers.
- Ability to interpret data and provide feedback to management
- Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198.
- Ability to support technical teams toward business goals.
- Ability to allocate and balance competing priorities
- Competency in understanding system functionality in relation to process requirements.
- Fluent in English, ability to travel internationally as needed. Ability to work outside of normal working hours when needed.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality Systems
Description
Position Summary
The Complaint Vigilance, Analyst 3 is expected to:
- Possess detailed knowledge of Janssen products and manufacturing sites to allow for independent triage of product quality complaints in order to execute a thorough complaint assessment in accordance with Standard Operating Procedures while utilizing the Product Quality Management System. This may include but is not limited to, review of the event reported, determination of the defect category, criticality assessment, recovery of field samples for evaluation (US only), follow-up with complainant (US only), and ensuring timely communication to management when applicable
- Exhibit strong ability to collaborate and influence Business Partners (Internal JSC Manufacturing sites, External Business Partners, regional ESIQ organizations, Call Intake Centers, and Global Medical Safety/LSOs, Brand Protection, etc) to ensure appropriate complaint handling and improve complaint management processes.
- Develop and deliver appropriate training to complaint management system end users.
- Identify and implement complaint process efficiencies. This will include assessing the impact of proposed changes within and across functional areas that impacts the complaint handling process.
- Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects
COMPLAINT MANAGEMENT:
- Process and analyze product complaints according to Policies and Standard Operating Procedures.
- Evaluate product quality complaints for seriousness, correctness and consistency of categorization.
- Assign complaints to appropriate investigational sites.
- Communication of potential serious PQC’s in a timely manner, as appropriate.
- Retrieval of field samples (US only), as applicable.
- Ensure all relevant complaint data is obtained.
- Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc.) to gain knowledge of products and processes.
- Facilitate and participate within process of auditing Complaint Records to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making.
- Compile product and site-specific complaint trending data and complaint closure metrics as requested.
- Support internal and external audits and inspections.
- Participate within and/or facilitate special projects.
BUSINESS RELATIONS:
- Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, etc.) to continuously identify, assess, and improve complaint handling processes.
- Build consensus across functional areas
- Drive technical and process improvements. Influence change.
- Solicit customer feedback.
DOCUMENTATION:
- Create, revise and maintain applicable department WI’s and SOPs.
- Identify, assess, and implement process improvements to the standard process.
- Develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.
- Audit Complaint Records in PQMS to ensure standard process is being followed, and complaints are closed as required. Compile product and site-specific complaint trending data and complaint closure metrics as requested. Support internal and external audits and inspections.
EXTERNAL AND INTERNAL INTERACTIONS
- May interact with other J&J operating companies to harmonize complaint management processes and procedures.
- Interacts with product quality complaint handling, manufacturing and quality personnel at internal manufacturing sites across JSC and external partners.
- Interacts with safety and surveillance personnel at Global Medical Safety for investigation of adverse events with potential product quality issues.
- Provides support for internal audits and inspections by regulatory authorities.
- Analyzes data and other trends, and presents to management.
STEP-BE
Qualifications
Education:
- Bachelor Degree in Physical Sciences or Life Sciences, or equivalent experience is required; Master Degree can be an asset.
- Project management / PMP Certification is an asset.
Related experience:
- 4years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related or highly regulated industry.
- Relevant knowledge on root cause investigations (production, lab environment)
- Strong communication, organizational and project management skills.
- Prior demonstrated success at Analyst 2 level or equivalent.
Job Specific Competencies:
- Strong interdependent partnering skills, interpersonal communication, influencing skills.
- Can work independently in a global environment/virtual team
- Global mindset
- Ability to lead change initiatives, develop strong effective relationships with key resources and decision makers.
- Ability to interpret data and provide feedback to management
- Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198.
- Ability to support technical teams toward business goals.
- Ability to allocate and balance competing priorities
- Competency in understanding system functionality in relation to process requirements.
- Fluent in English, ability to travel internationally as needed. Ability to work outside of normal working hours when needed.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality Systems