- Professional
- Optionales Büro in Pune
Job Description
1. Review of Biotech R&D Documents as per ALCOA++ requirements, metadata review,
and data integrity checks.
2. 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.
3. QAMS review support for evaluation and approval of Quality Management
notifications such as deviation, Change Control, CAPA and LIR.
4. 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 .
5. 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.
6. Conducting Internal Audit for R&D for compliance checks.
7. Support in implementing new systems at R&D as part of system improvisation.
8. Support in Archival, Issuance and destruction of R&D documents.
Work Experience
6-10 Years
