Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
Supports the development and management of GMP compliance systems by developing and implementing processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
Carries out tasks related to the administration of site nonconformance management systems
Carries out tasks related to the management of site change control systems
Supports system qualification and process validation activities
Carries out administration of the Supplier Assessment, Auditing and Inspection Readiness Systems at the site
Supports GMP training activities
Carries out tasks related to the administration of site supplier approval systems
Carries out tasks related to the management of batch records design and release systems
Supports system process support validation and process validation activities
Carries out administration of the SAP Quality Management Module for JJIM
Reviews and approves SOPs/work instructions/forms/validation plans from other departments on behalf of Quality Assurance.
Deputises for the Quality Assurance as appropriate.
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