Overview
QA Technician GMP systems documentation, training and CAPAs
Responsibilities
* Company document system.
* GMP document management of the plant in computerized systems (trackwise or similar) and on paper.
* Issuance and review of the documents included in the system.
* Issuance of GMP documentation and control.
* Evaluation and implementation of changes in the document system, whether internal or established by the company's global department.
* Control and archiving of the documents and records of the Quality System in what refers to its area of competence.
* GMP Training System
* Collaborate with other areas in the preparation of the annual GMP training plans for the staff.
* Follow-up and issuance of annual reports on compliance with the training plan.
* Management of training in the computerized system (trackwise or similar) and on paper
* CAPA System
* Management of the company's corrective and preventive actions by evaluating the opening, review and closure together with the departments involved.
* Review of the verification of effectiveness.
* Generation of periodic reports and KPIs of the system.
* Carrying out the general operations applicable to the QA system department
* Support in client, agency and internal audits
* Support in the investigation of quality events and complaints applicable to the position
* Updating and creating procedures and forms
* Participation in the qualifications/validations of your department's systems.
* Participation in the necessary meetings with other departments, company plant or customers.
Qualifications
University studies or proven experience in a similar position (2 years)
English
Office