SENIOR MANAGER
BengaluruFull-timeSenior levelPosted 1 week ago
Senior pharma role at Biocon in Bengaluru.
About the role
Promote a strong quality culture emphasizing data integrity and regulatory compliance. Determine audit focus areas based on risk, previous findings, and regulatory expectations. Decide on acceptability and corrective actions for deviations, outofspecifications OOS, and quality incidents. Prioritize training topics and continuous improvement initiatives based on audit outcomes and quality trends.
What you'll do
- Work experience (in months)
- Manage QA oversight of nonclinical and clinical RD studies including method development, process development, and pilot manufacturing
- Ensure compliance with applicable regulatory frameworks GLP, GMP, GCP
- Plan and lead internal audits of RD labs, processes, and documentation
- Support external regulatory inspections and customer audits by preparing teams and documentation
What you need
- GLP
- GMP
- Regulatory affairs
- Documentation
- Quality control
- GCP
Good to have
- Internal audit
- SOP writing
- Root cause analysis