Â Who are you?
- Minimum 5 years QA and/or CMC experience or relevant experience in pharmaceutical and/or biotech industry
- Graduate degree in pharmacy or chemistry or related.
- Experience with Quality Systems implementation / administration.
- Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance - including those related to Risk Based Quality Assurance.
- Good knowledge of GMPs, ISO 9001 and other relevant quality systems
What will you do?
- Recognize those areas of quality systems that exhibit an opportunity for improvement (ex. Documentation management, Training, Regulatory submissions, etc.) based upon business, customer, and regulatory requirements and develop, implement, and maintain these Quality Systems to ensure a level at or above industry standards
- Work with other departments, divisions, and sites to solve problems, improve service, reduce costs, and enhance programs within the Quality Management System;
- To follow-up the notifications of the health authorities and propose actions for compliance.
- To follow-up the CMO projects as quality representative when it necessary.
- Collaborate with the implementation of the Quality Systems processes in Brazil (process and procedures);
- Provide support in all GxP trainings related (GMP, GCP, GLP, etc);
- Collaborate with the Quality Manual implementation and administration in the site when applicable;
- Facilitate the implementation of CH standards, maintain a documentation system and ensure that all procedures are in line with the global procedures and are regularly updated;
- Ensure deviations are identified, recorded, investigated, approved and closed in the Merck CH and as well in Merck Biopharma with impact in CH;
- Ensure that corrective and preventive actions are timely defined, documented, tracked and closed in order to improve continuously the quality of the quality processes;
- Ensure the complaints process in accordingly performed as per Merck CH guidelines;
- Interact with drug and food safety department ensuring compliance with the pharmacovigilance process;
- Monitor the KPIs and collaborate with the Quality Management Review;