Commercial Quality Specialist

hace 5 días

Bogotá, Colombia Johnson & Johnson A tiempo completo

**Job Function**:
Quality

**Job Sub**Function**:
Customer/Commercial Quality

**Job Category**:
Professional

**All Job Posting Locations**:
Bogotá, Distrito Capital, Colombia

We are searching for the best talent for Total Rewards Benefits Analyst to be based in Bogotá

**The Commercial Quality Specialist will**:

- Conducts Supplier & Distributor audits.
- Manage the activities associated with the selection, qualification and approval of products or services suppliers/distributors that are within the scope of the quality management system, in accordance with current procedures.
- Ensure the maintenance of suppliers and distributors requirements qualification.
- Perform transactions in SAP for develop the master data process approval as DDL or GMP.
- Support responses to address external audit and inspections.
- Responsible for reporting, tracking and timely closure of audit (supplier, distributor & external) applicable corrective and preventive actions.
- Management PQI and RC Alerts
- Performs & reports compliance metrics and drive improvement on those metrics.
- Management of technical assistance complaints, ensuring that actions plans are defined and communicated to customers as applicable.
- Support the execution of the change controls, when applicable.
- Support the execution of the complaint management process within the guidelines defined by the company
- Execute the Post Market Surveillance processes: Technovigilance.
- Execute local process for Compliance Alerts (FA, SS, Recall Etc..) ensuring that notifications are carried out and the affected product is handled in a timely manner, in line with current procedures.
- Execute the CRAC (Regional coordinator of field actions) role when applicable.
- Support the implementation of company standards such as: Temperature Control, Loaner Kits, Repack and Relabel, among others as applicable.
- Support activities to execute the Management Review process.
- Ensure compliance with Intercompany Quality Agreements Requirements.
- Support the creation of the purchase orders relative to the process in the Commercial Quality area.Document Non-Conformities in the DES; ensuring compliance with the different stages: identification, investigation, cause analysis, correction, implementation of corrective and preventive actions and verification of effectiveness.

**Qualifications**:

- A minimum of 5 years of work experience in Quality Systems (Good Manufacturing Practices) is required.
- Experience being a Lead Auditor
- Title of pharmacist, life sciences, engineering, or other fields related to health sciences with expertise in Quality Systems.
- English proficiency is required.
- Proficiency in Microsoft Office is required.
- Knowledge in SAP is desirable.
- Strong analytical skills to identify areas for improvement in quality processes.

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