Proficient in eCTD submissions and managing post-approval changes (Level I / II) Proficient in FDA-compliant SPL labelling lifecycle managementPreferred candidate profile Extensive experience in eCTD...view more
Role & responsibilities 1) Responsible for PLC validation and performing CSV of plant equipment work as per cGMP & GDP.2) Responsible for the operation of all QMS documents of plant process equipmen...view more