assigned portfolio of products: Assisting with internal product queries from relevant departments Assisting regulatory authorities Work in collaboration with internal and external stakeholders to assess regulator's Guidelines pertaining to the pharmaceutical industry. Internal training and mentoring Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders Formulate or implement maintained or enhanced. Support activities such as internal audits or regulatory agency inspections Ensure alignment
local GMP Audit program and conduct external audits and self-inspections as per the GMP Audit Schedule that global audits are performed by the Group QA team as per Audit Schedule, and that audit reports and Management meetings. Manage all Deviations (both internal and from external suppliers) as per approved processes Ensure that all CAPA's raised out of an external audit are managed according to the time frames allocated
local GMP Audit program and conduct external audits and self-inspections as per the GMP Audit Schedule that global audits are performed by the Group QA team as per Audit Schedule, and that audit reports and Management meetings. Manage all Deviations (both internal and from external suppliers) as per approved processes Ensure that all CAPA's raised out of an external audit are managed according to the time frames allocated
Tracking Regulatory Activity Internal training Assisting with internal product queries from relevant
and Site Master Files in place Conduct external audits to ensure that systems are in place to maintain
and Site Master Files in place Conduct external audits to ensure that systems are in place to maintain