QUALITY SYSTEM ANALYST (Fixed term) - Mexico City

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Mexico City, Mexico

Job Description:

The Quality Systems Analyst gives support in Inspection and Release of finished product (basic box labeling or govern sales).

Execution of activities corresponding to inspection, ruling (release/rejection) of product from rejections and returns (from customers) as well as additional activities in reverse logistics processes that provide benefits to the business, providing support in audits and the quality in the Distribution Center.


* Registration in books for controlled drug, receipt, returns and rejections.

Sensor management and evaluation of temperature excursions.


* Supervision and monitoring of GAP in the distribution center (Gembawalking).


* Ensure compliance with Good Storage and Distribution Practices.


* Blocking and unlocking of materials in SAP.


* Opening and tracking of records in COMET related to Quality issues.


* Collaboration with other areas (Planning, Delivery Operations, Customer Service and Commercial Areas) in the labeling of products for government sales in accordance with J&J standards for controlled and non-controlled drugs.


* Collaboration in the QMS, to monitor Non-conformities, CAPA's and Change Controls


* Reverse logistics, SAP opinion of returns and rejections in the pharmaceutical sector; Follow-up on customer complaints, preparation of explanatory letters for customers.


* Support in document control in TruVault for Janssen de Mexico.


* Deployment of J&J standards, gap assessment and monitoring for implementation in the distribution center.


* Perform related duties as assigned by supervisor.


* Maintain compliance with all company policies and procedures.

Minimum Qualification


* University degree as a pharmacist (QFB or QFI), or Industrial or Chemical Engineering


* Basic knowledge of industry Quality Systems.


* The position requires at least 2 - 3 years of experience in the Pharmaceutical Industry.


* Basic knowledge of GxP (Good Practices) and desirably of national health regulation applicable to • pharmaceuticals (standards and laws).


* Focus on results and strategic thinking.

Health legislation knowledge

Other requirements


* Must be able to lift and carry up to 50 ibs.


* At this level, the role has increased responsibility, inc...