Effective regular GEMBA walk to improve quality operations in DC
- Accurate and timely communication of temperature control excursions occurring within J&J Distribution Center
- Prepare metrics for Management Review and track all after review actions to closure.
- To create and/or review the related procedures, organization chart and documentation based on current practice and regulation (e.g SOPs, training matrix) and assure training is assigned to all related personnel, include warehouse personnel
- Implement records and document management in accordance with J&J procedures.
- As PJT Review and sign letters to MoH, e.g on product registration submissions, product destruction report and others mandatory reporting, with the collaboration with related functions (MD, VC and Consumer MD)
- Organize the logistics activities to prepare the site for External/Third party audits and regulatory inspections
- Raise /Follow up and Closure of CAPAs generated from Audit/ Regulatory Inspection.
- Lead, plan and implement audit program of Third Party/service providers to ensure compliance.
- Provide disposition on the damage products, as per provided guideline from franchise.
- Own and/or oversee the day-to-day running of the CAPA systems
- Undertake troubleshooting and solutions, root cause analysis to quality issues
- As PJT Review / witness final product destruction at destruction company
- As PJT Prepare and submit destruction report to MoH every final destruction at destruction company
- As PJT review and approve labeling activities report (such as batch record) from VAS team
- E2E support execution and Follow-up all product quality holds and field actions
- Submit required report to MoH in timely manner, such as E-Watch for Nil adverse event report of medical devices
- Own and oversee the day-to-day running of the Complaint Management System
**Qualifications**
- Minimum bachelor's or master's degree in Life Sciences, Engineering or health-related discipline.
- Minimum of 2 years in the Medical Device Segment or pharmaceutical, healthcare industry
- Certified lead auditor or prior auditing experience in a regulated environment
- Proven track record of leading or coaching teams to achieve significant quality and process improvement
- Experience with GDP of Medical Devices, ISO 13485 or equivalent quality standard program preferred
- Strong ability to influence others decision that will benefit the company as a whole
- Demonstrated ability on project management, analytical and process-oriented.
Sufficient knowledge on GDP of Medical Devices Regulation, J&J Quality and Technical Standards, Commercial Qulaity SOPs, Sector/Regional procedures, GxPs, regulations, and other quality systems and guidelines.
- Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
- Leadership, collaboration, and interpersonal skills
- Communication, presentation and management skills.
- Experiences and familiar with Warehouse and Operational Activities
**Primary Location**
Indonesia-Jawa-Jakarta Raya
- **Organization**
P.T.
Johnson & Johnson Indonesia (8150)
**Job Function**
Quality
**Requisition ID**
2206004078W