Quality Sys Spec I

Snapshot of your day:

- Trigger and conclude all activities related to the process of incidents and returns

- Collect information and follow up until the conclusion of the complaints process

- Generate the back labels (legal labels) of the products in a timely manner prior to the conclusion of the

period to deplete inventories.

- Execute the planning regarding the generation of evidence for audits

- Keep the bases of the SGC updated

- Ensure that the SGC documents are current

- Carry out the activities as Assistant of the UTV for issuing the five-year report, analysis of trends, implementation and training of the current applicable regulations

How you will Make an Impact: 

- Maintain control of the incident and return process that keeps the areas working together continuously and reduces the execution times of actions in the inventory.

- Maintain control of the QMS documentation system in order to respond in a timely manner to planned and unplanned audits (auditing the system documentation)

- Provide solutions to extremely complex problems in which data analysis requires an evaluation of intangible variables.

- Update controls, build and maintain files of documents and correspondence sent and received by the Authority in accordance with the processes agreed at global and local levels.

What you  Bring:

KNOWLEDGE

- Knowledge of the regulations applicable to DM IVD - Knowledge of QMS

- Knowledge of the Technovigilance process

- Management of the SAP system SKILLS

- Ease of interacting with different areas at different levels to achieve objectives

- Attention to detail

- Administration and Time Management

- Ease of issuing Quality documentation

- Technological adaptability

– Management of new technologies

- Deep analytical aptitude

– Id discrepancies, patterns and trends to see possible risks - Tolerance to frustration

WORK EXPERIENCE

- Having worked in companies with health products

- Having participated in Audits

- Experience in quality processes including product release and incident monitoring