Ensure completion of APQRs within defined timelines. Archival of the approved APQRs as applicable. Communicate with external suppliers to provide applicable approved supplier APQR and related documents to QOP.
Bachelor degree in a relevant field, such as Life Sciences or Healthcare. Proven experience in clinical data management within the pharmaceutical or biotechnology industry. ICON plc
Basic knowledge of medical terminologies and able to understand common medical terms relevant to pharmacovigilance and adverse event reporting. Elanco Animal Health
Review QMS documents, SOPs, processes and records for compliance with GMP requirements; Support OOS, OOT, deviations, change controls, CAPA, risk assessments and investigations; Ensure compliance with ALCOA+ data integrity principles
To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
Assist in day-to-day production activities as per SOPs. Conduct basic chemical handling, mixing, and batch processing.
Monitor production processes and record process parameters.