Support the QA department in the development, implementation, communication, and maintenance of quality system policies and procedures to ensure compliance with regulatory requirements related to Good Manufacturing Practices (GMP) for the manufacture, packaging, analysis, and distribution of solid oral pharmaceutical products for the U.S. market (US FDA), European (EMA), and Canadian (Health Canada) markets.

Duties and responsibilities:

• Develop and maintain internal quality procedures and systems to ensure compliance with GMP.

• Maintain, support and improve the following program and processes:

-Corrective and preventive action program (CAPA);

-Internal audit program;

-Suppliers qualification program;

-Control of documents and Change control;

-Client Complaint Management Process;

-Continuous quality improvement process;

-GMP training program for employees;

-Cleaning verification program;

-Environmental Monitoring Program;

• Support the upper management for:

-Monitor and assess quality system effectiveness.

-Improve productivity and/or diversification the company’s services or

markets in order to ensure compliance with GMP.

• Support QA department during audits (clients, internal, regulatory authorities

and suppliers) of the company's quality systems.

• Approval of Manufacturing, Packaging, and Labelling Master Files.

• Issuance of manufacturing, packaging and labelling files.

• Make risk assessments when introducing a new API in the company or during a change.

• Make clearances of production rooms and check of cleanliness of equipment.

• Revision of Reception files.

• Revision/writing of Raw Materials and Packaging Components specifications.

-Review of Raw Materials, Packaging Components and Finished Product certificate of analysis.

-Review of Executed Production Files (Manufacturing, packaging and labelling).

-Révision des rapports sommaires de stabilité. / Review of Stability Summary Reports.

• Toutes tâches connexes. / Any related tasks.