TECHNICAL QUALITY FOR API

Description

Ensure the culture of quality in plants:

• Ensure that the procedures established by the company are followed during all phases of production to guarantee the safety of products
• Review production methods (MP's), spreadsheets in process (Batch Records) and all associated documentation in situ (logbooks of equipment, cleanings, interventions) when necessary, to ensure that the processes are carried out according to the procedures described.
• Verify that the "In Process Control" are carried out in accordance with the procedures described, with equipment and instruments in a correct state of calibration and qualification.

Actively participate in the improvement of quality management in the plant:

• Propose and participate in the improvement of procedures and processes related to quality
• Work with department managers to improve the quality of the company's processes and products
• Member of the multidisciplinary teams for the development of Product and Process Risk Analysis.
   

Provide support during investigations of any incident or deviation as necessary:

• Record and report the deviations detected in MasterControl.
• Collaborate in the investigations of deviations or non-conformities (Root Cause Analysis, FTA), as well as in the implementation of corrective and/or preventive actions (CAPA).

Promote the culture of quality:

• Conducting training for production personnel on Quality issues
• Provide support during inspections and audits.

Requirements

• Bachelor's degree in science or higher vocational training (biology, chemistry, biotechnology, pharmacy or similar).
• 5 years in pharmaceutical industry (production, quality assurance, industrialization).