MAIN DUTIES AND RESPONSABILITIES
As Quality Affairs Trainee...
Distribution activities Verify compliance of all batch documentation for release, including control of certificates of analysis and monitoring of temperature conditions during shipment Support handling of product quality complaints, including notification, follow-up and feedback to customers. Support handling of customer requests, including management of records in iCONNECT and feedback to customers. Support recall processes Support handling of Narcotic Import Licenses requested to Health Authority Support daily management of Narcotic documentation sent with deliveries (Anexo VII) Support preparation of Periodic Quality Reports (General Activities, Complaints, Narcotics) Support preparation of Annual Product Review/Product Quality Review for all products marketed by Janssen
Quality System Maintenance
Collaborate on the management of Quality Issues, Change Controls and Risk Assessment activities Support preparation and participate on the Internal Audits related to quality activities Support update of Business Quality Manual Archive all Quality relevant documentation
As Regulatory Affaiirs trainee...
Support preparation and submission of Market Authorization variations Support translation and review of labelling documents Support the process of development and implementation of packaging materials Support preparation of responses to requests for information Proceed to the HA notification of promotional materials according to the local advertising legal requirements Manage Promotional Materials documentation and samples archive Support preparation and participate on the Internal Audits related to regulatory activities Archive all Regulatory relevant documentation
Required Education & Experience: University Degree in Pharmacy, Biology, Chemistry or related Life Science Fluent in portuguese and english
Skills and Abilities:
- Adaptability and Flexibility - Strong Interpersonal, communication and teamwork skills - Ability to manage multiple tasks, projects, priorities and complex systems simultaneously - Ability to work under strict timelines, combined with flexibility when emergency situations require this
Janssen-Cilag Farmaceutica, Lda. (7290)