Commercial Quality Analyst

hace 1 semana

Bogota, Colombia Johnson & Johnson A tiempo completo

Ensure compliance with J&J policies and procedures described in the Quality Management System applicable to the Marketing Company, distribution channels and requirements indicated by Local Quality Regulations. Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Ensure compliance for training and qualification program, records management and document control, change control process and samples management for human and non-human use. Ensure compliance with J&J policies and procedures described in the Quality Management System applicable to the role.

Responsability

1.Ensure compliance with company policies, procedures, and quality standards

2.Support investigations of Quality Issues and definition of preventive and corrective actions through the analysis of root causes and participate in the meetings with the other areas involved.

3.Manage the training process, ensuring compliance with the metric defined for timelines and completion and complying with the minimum requirements established in the Curriculum Matrix

4. Change Control execution process support, ensuring that the changes are evaluated, registered, reviewed, and approved prior to implementation

5. Technovigilance Surveillance Responsible: Manage and report to health authority any event or serious adverse event of a medical device, as provided in resolution 4816 of 2008.

6. Support the process related to the technology-controlled reports,Quarterly Reports, traceability according to the frequency established by health authority.

7..Support the Product Complaint process in Colombia and support the Post-market surveillance program quality

8. Support the creation of the purchase orders relative to the process in the CommercialBusiness Quality area

9..Perform handling material data transactions in SAP.

10.Support with all relevant aspects during the receipt of local or external Regulatory Bodies inspection.

**Qualifications**:
1.Minimum 2 years of work experience is required in Quality Systems (Good Manufacturing Practices) preferably in medical devices companies.

2.A Bachelor's degree is required. A degree in science, engineering, chemistry, administration or related field is preferred

3. English 70%.

**Skills**:Strong written and verbal communication skills-Management of complexity-Planning and organization skills.Effective and assertive communication skills - Written and verbal.Ability to work under pressure.Skills for prioritization of activities and sense of urgency.Strong teamwork and connect skills-Good communication skills in English and Spanish-Results oriented

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