AddressResponsible for Management of Regulatory authority and other external compliance audits (e.g. customer audits) including communication, tracking and resolution of observations. Management of communications with Regulatory agencies including required reporting and resolution of any actions required by the agencies.
Responsible for Assessment of the Regulatory compliance status of the site with implementation of CAPA to assure compliance. This includes review of major/critical observations from other Teva sites and implementation of CAPA as appropriate. Requirement for sites to remain inspection ready at all times.
Responsible for Performance, reporting, and execution / management of internal compliance audits including communication, tracking and resolution of observations.
Responsible for Review of regulatory and quality compliance requirements, inspection outcomes, Global Notifications to Management, and performance of gap assessments covering all areas of applicability. Monitoring of corrective action plans where needed.
Maintaining as well as responsible for establishment of appropriate licensing of a site with the regulatory bodies where products are marketed.
Responsible for execution of the site Quality council meetings including preparation, presentation, and tracking of resultant actions.
Responsible for Establishment/review of QTA’s with suppliers/subcontractors/service providers required for the site. Establishment/review of QTA with customers (TAPI as supplier).
Responsible for Oversight and review of suppliers and materials for use in production and processes.
Responsible for Drafting, approval and maintenance of a Site Master File (SMF).
Ensuring Quality interface with internal and external customers when dealing with activities such as QTAs, supplier qualification, issue resolution, product information, or for movement of materials, products, or process from site to site.
Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records.
Additional responsibilities assigned by the Manager – QA /Site Quality Head.
