Johnson & Johnson Careers

Business Quality Coordinator

Bogotá, Colombia
Quality (Generalist)


Job Description

Requisition ID: 1905767804W

Coordinates and supports directs quality assurance processes designed to ensure continuous supply of products in accordance to applicable requirements, working in alignment to different stakeholders (Deliver, Deliver Quality, Supply Chain, Regulatory Affairs, Manufacturing sites), in an accurate and timely manner. Coordinates and support the implementation of QMS in the cluster with focus on purchasing controls, documentation, change controls, audits and quality event management, among others.

- Ensure that documentation and operations meet established requirements of cGMPs, J&J SOPs and enterprise policies.

- Ensures the maintenance of quality records on technical documentation, Product Master Data, repack and relabeling, product release, nonconformance, E2E Labeling, project outcomes, and that stakeholder input is filed in an accurate and timely manner.

- Reviews and audits change control documentation and tracks the approval process.

- Contributes to the development of corrective action plans and monitors implementation.

- Reports on closure of corrective and preventive actions.

- Checks and reviews quality surveys regarding support for technology transfer and improvement of existing manufacturing processes.

- Monitors and leads investigations, recognizes trends and presents reports for assigned quality processes.

- Reviews reports on current quality systems and supports improvements in order to improve quality and reduce cycle time.

- Assures preparation for audits and inspections.

- Monitors trends, identifies issues, recommends and implements appropriate actions.

- Develops, implements and reviews standard operating procedures and working instructions for interactions with BQ process and stakeholders.

- Has deep understanding of process criteria and regulations and business impact of decisions and actions.

- Leads and assists quality analysts



Qualifications

ARE YOU PASSIONATE ABOUT THIS ROLE? SEE THE REQUIREMENTS BELOW
- Your area of study should be pharmaceutical chemestry, engineering, among others.

- Professional experience of 7+ years in Quality and implementation of quality systems in pharmaceutical industry.

- Knowledge and skills in SAP (required) - FSCM Module (preferable).

- If you have prior Excel, knowledge in Regulatory.

- Bilingual (English- Spanish) if you know Portuguese that is a plus


DID YOU KNOW?
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.


INTERNAL DISCLAIMERS:
If you want to apply to this position, please consider the following information from our Global Job Posting Policy

- The employee has spent at least 18 months in his/her current position, and

- The employee is in good standing.

- Manager Notification - An employee may apply for a position without informing his/her manager. However, if you are invited to interview for a role, then, to the extent that this is consistent with local law or practice, s/he is required to notify his/her direct leader prior to the interview. This notification seeks to promote development discussions between the manager and the employee.



Primary Location
Colombia-Distrito Capital de Bogotá-Bogotá-
Organization
Janssen Cilag S.A. (7060)
Job Function
Quality (Generalist)
Requisition ID
1905767804W