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