Review of Biotech R&D Documents as per ALCOA++ requirements, metadata review, and data integrity checks.
Review of Process Development Reports, Tech transfer documents, Process Characterization Reports. Co-ordination from DOA end to support for Tech transfer activities. Review of Clone Development, Clone Characterization and Packaging Documents.
QAMS review support for evaluation and approval of Quality Management notifications such as deviation, Change Control, CAPA and LIR.
QAMS Management: Tracking of QAMS Notifications, co-ordination with R&D for QAMS related activities, Periodic Review and Trending as per SOP and troubleshooting of QAMS system .
Co-ordination with CQA and HO-IT for implementation of Corporate SOPs at Biotech R&D and Management of QAMS for R&D Biotech site for Corporate Change controls.
Conducting Internal Audit for R&D for compliance checks.
Support in implementing new systems at R&D as part of system improvisation.
Support in Archival, Issuance and destruction of R&D documents.

Associate Scientist - DQA