
Sr Quality Assurance Manager
- São Paulo - SP
- Permanente
- Período integral
- Ensure compliance with Quality and Compliance requirements in relation to Good Manufacturing Practices, Good Documentation Practices and Data Integrity;
- Ensure compliance with global Quality, Safety, Delivery and Productivity metrics;
- Support in the Manufacturing area during daily routines for all manufacturing shifts;
- Ensure that decision-making is carried out in a timely manner, so as not to impact the supply of products to the market;
- Participate in the Site leadership forums: Fast Response, Zone Control, CAPA review Board and Quality Management Review;
- Develop the annual strategic planning for project establishment and team metrics;
- Perform GEMBAs for Quality Investigations, Safety or for definitions of process improvements;
- Coordinate the process of releasing batches of finished goods to market;
- Manage the people of the QA Assurance (Operations) department;
- Participate in and promote the ICare program with a focus on quality (BBQ);
- Participate and influence the automation and digitalization processes of manufacturing processes;
- Evaluate deviations in batch documentation, either on paper or electronically;
- Perform and Evaluate Routine Inspections in Production Areas and Support Areas;
- Ensure compliance verification during the process of releasing batches of finished goods;
- Ensure batch release within corporate deadlines and requirements;
- Monitor process performance indicators and act on opportunities;
- Execution of ACEs, as well as compliance with metrics and action plans from ACEs or Individual Development Programs;
- Actively participate in the definition of strategies for the site;
- Represent SQH in assignments when delegated or in their absence on the site;
- Promote a quality culture in productive processes;
- Bachelor's Degree in Biochemistry Pharmacy;
- Long term interaction with ANVISA, its Regulations and working within a pharmaceutical GMP environment.
- Fluent in English.
- Proven leadership and excellent communication skills
- Relationship skill with internal and external clients.
- Long range visibility and planning capability.