QA Manager

The requirements necessary to exercise the Quality Assurance Manager Professional Category are:

-Higher degree in life sciences, such as Biology, Chemistry, Natural Sciences, Pharmaceuticals, Biotechnology, among others.

– Must have knowledge of Good Manufacturing Practices (GMP) and Good Agricultural and Collection Practice (GACP) Standards.

– Possess ability to assess and manage risks.

– Have professional experience in the Pharmaceutical or Food Industry.

– Strong leadership and communication skills.

– Knowledge of Quality Systems and processes.

Assure compliance with EU-GMP and GACP and legislative requirements.

– Manage the Quality Management System, ensuring its implementation and maintenance.

– Ensure that all necessary Quality Assurance System procedures are clearly defined and systematically reviewed.

– Develop, maintain, file and periodically update the Quality Management System.

– Elaborate, revise, approve the general procedures of the Quality Management System, including its modifications.

-Ensure that the necessary records are systematically in place to demonstrate that the necessary sampling, inspection and control procedures are carried out.

-Maintain and manage the documentation of the analysed batches, ensuring the traceability of all analyses carried out.

-Ensure that any deviations are fully recorded and investigated.

-Verify that investigations are carried out on detected deviations, duly documenting the results obtained and the conclusions issued.

-Establish an adequate, initial and continuous training plan to ensure that employees have the necessary training to carry out their activities correctly.

-Ensure that maintenance of facilities and equipment is carried out in accordance with applicable legal requirements.

-Update and maintain the Quality Management System to ensure compliance with GACP and EU-GMP guidelines.

-Manage the Quality Assurance Department.

-Ensure that proper calibration, qualification and validation of equipment (including validations of test methods) is carried out.

– Supervise Production Managers and workers to implement the procedures (SOP´s) necessary to meet GACP and EU-GMP guidelines.

– Prepare for and participate in all third-party audits and inspections.