Johnson & Johnson Carreiras
Make Quality Operations Coordinator
Descrição da Vaga
Requisition ID: 9081180808
Lead Compromised Skin plants – SJC site Quality Operations team activities.
Supervises the daily activities of the quality operations team.
Partnership with local Q&C team in order to guarantee a robust deployment of compliance requirements.
Plans, lead, and directs quality operations programs designed to ensure compliance to Johnson&Johnson Consumer requirements by performing the following duties personally or through subordinates.
Leads and participates in Quality & Compliance improvement initiatives.
Guarantee compliance with regulatory and J&J requirements for the implementation of changes in production methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines and other factors.
Report, analyze and propose actions for KPIs, as needed.
Supports non conformance, Change Control and CAPA process.
Provides input to quality control reports, requirements and other information in response to requests for proposals, quotes and other business opportunities.
Leads improvements and CIP projects, locally and/or regionally.
Leads gap assessment to identify opportunities versus internal procedures and external regulations.
Makes recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production costs.
Act in a timely manner and independently on decision making process considering a wide range of Quality and compliance issues.
Partner with adjacent areas of the business to build a robust strategy to achieve the committed goals.
B.Sc. or equivalent degree in a science discipline (chemistry, microbiology, pharmacy, engineering)
At least 05 years Experience in Quality Operations at Pharmaceutical or Medical Devices Industries.
Fluency in English.
Knowledge in ANVISA regulation applicable to Medical Devices and Drugs.
Post Graduation in Quality Engineering or Green Belt Certification.
Knowledge in statistical skills, ISO 13485 and FDA regulations.
Brasil-São Paulo-São José dos Campos
J&J Brazil (7680)