Job purpose:

- Responsible for handling the Pharmacovigilance plan and compliance with regulations (file submission, layouts review, nitrosamine and elemental impurities)

- Responsible for handling new projects related to GMP and new guidelines implementation.

- Perform duties in accordance with Malia Group Policies and Procedures.

Duties and responsibilities

On Standard Operating Procedures and Documentation
- Write and continuously update SOPs and work instructions for all departments, once validated by management ensure proper implementation of procedures
- Conduct training sessions to all plant staff on any new or updated SOP, basic GMP requirements, and other topics according to set schedule
- Monitor, review and ensure implementation of pharmacovigilance plan
- Review and approve quality agreements for service providers, suppliers and licensors and ensure timely execution

On Internal Inspections & Audits
- Prepare and follow up on risk assessment, impact assessment and worse case studies for products, processes, equipment, methods and systems with concerned departments
-Conduct and monitor internal audits and self-inspections to ensure GMP guidelines are respected

-Ensure proper implementation of corrective or preventive actions after self-inspections and external audits



On Reporting
- Conduct full investigation, monitoring and follow up on compliance of regulations (file submission, layouts review, nitrosamine and elemental impurities) for products and take corrective actions
- Prepare trend analysis reports and propose process modification upon need
- Review batch files related to production activities and related analytical data for finished products release



On New Projects
- Contribute with other departments in new projects to fulfill GMP guidelines and handle any related inquiries
- Handle the continuous search and upgrade of quality systems and guidelines

Education
- BS in Pharmacy

Experience
- Up to 1 year of related experience