Job Summary

Responsible for ensuring the Analytical data review Review & Approval of Lab events OOS,OOT

Job Responsibilities
- Responsible to monitor the Analytical data review performed by review team.
- Responsible to monitor the investigations performed by QC investigation team.
- Review & Approval of Lab events, Out of specification results (LIRs), Out of trend (OOTs), Deviations, Anomalous results Investigation reports.
- Coordination with cross functional departments for smooth functioning of analytical activities.
- Review and approval of deviations in Track wise.
- Review and approval of Certificate of analysis (COAs).
- Review and approval of Specifications in LIMS and approvals of SOPs and STPs.
- Monitoring of stability studies activities, Review and approval of shelf life certificates & Protocols.
- Approval of protocols & reports of analytical method validations, verifications, Transfers and risk assessment reports.
- Approval of certificate of analysis of reference standards & Impurity standards.




- Preparation/Approval of SOPs and forms related to analytical activities.
- To perform Change control impact assessments and approvals in Trask wise.
- To perform un-announced Realtime checks and Internal audits as per the Schedule.
- Managing of Customer Request Samples activities.
- Coordination and providing the support for Business development and regulatory affairs activities.
- Batch release in SAP for Raw material, Solvents, Operational supplies (Packaging Materials, Filter bags etc..).
- Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employees progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working setting for all employees.
- Utilize open, honest, two way communication to build trust-based relationships with employees, b

📌 Manager - Quality Analytical Support (Bengaluru)
🏢 Apotex
📍 Bengaluru