PQR Specialist

Responsible for the preparation of the Product Quality Review (PQR) reports for marketed products in order to ensure that the manufacturing process is reproducible and controlled, that product quality is ensured by the implemented specifications, and to initiate   process improvements, as required.

Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, change controls etc.) and regulatory and stability data.

Responsible for the preparation of the PQR Report according to the established schedule.

Desired profile:

A Bachelor of Science degree in a scientific discipline

Fluent in both spoken and written English

Strong technical writing and communication skills, file organization, and the ability to manage data

Able to work independently, with a proactive approach to problem-solving and task management

Proficiency in usual MS Office is needed

Knowledge of cGMPs- an advantage