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QUALITY ASSURANCE SR. SUPERVISOR
São José dos Campos, Brazil
Requisition ID: 0298180502
External Manufacturer Quality&Compliance Coordinator
• Coordinates quality assurance programs and controls in External manufacturers and External contract labs within LatAm. Ensures performance and quality of products conform to established company and regulatory standards.
• Supervises the daily activities of the quality assurance analysts and other quality assurance activities. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Trains, plans, schedules and assigns work, appraises performance and solves problems.
• EMs Management, through support to quality processes, such as investigations of non-conformance, investigation of complaints, change control evaluation, Management Review, metrics and support in validations. Monitoring and evaluation of tendency of quality indicators, proposing and assisting in the implementation of these actions, when necessary.
• Approves, conducts and/or tracks quality investigations and process deviations and follows up to ensure corrective action has been taken. Investigates nonconformance as they pertain to the manufacturing and testing of company products.
• Carries out audits for qualification, focused and for cause of external manufacturing and external laboratory to evaluate the attendance to GMP, GPD, GLP and J&J policies. Prepares EMs for receiving JJRC audits.
• Conducts micro risk assessments in EMs which present microbiological risk.
• Be engaged in New Product Introduction (NPI)s projects and develops new EMs to meet the demands of Make.
• Supports COE activities in attendance to Source Quality Procedures
• Manages quality risks related to EM.
• Leads and participates in improvement initiatives.
• Bachelor's degree in Pharmacy, Chemistry, Engineering or Biology
• Knowledge and experience in quality tools, validation and manufacturing process
• Experience in Quality System and ANVISA/INVIMA/ANMAT regulations applicable to Cosmetics, Medical Devices and/or Drugs
• Advanced experience: Word / Excel / Power Point
• Minimum of 6 years related experience
• Minimum of 1 year with people management
• Communication skills
• Capable leader and team player able to interact and lead at various levels within the organization
• Advanced English.
• Lead Auditor certification.
Brazil-São Paulo-São José dos Campos
J&J Brazil (7680)