Key Responsibilities

- Responsible for Approval/Rejection of RM, PM, In-process, Finished product and stability samples
- Daily lab management- Responsible for allocation of analysis to QC analyst based on competency of analyst.
- Proficient in handling Lab instruments like HPLC, UV, IR, GC Potentiometer etc.
- Ensure analysis performed according to approved specifications, on calibrated instruments, and as per GLP compliance.
- Capable to handle CAPA, change control, Deviation, OOS, OOT and incidence, inspection and investigation
- Should have knowledge of ICH guidelines and their implementation.
- Review of analytical raw data, chromatograms, specs and instrument audit trials.
- Ensures all data generated in Lab in accordance to 21 CFR part 11 compliance
- Investigation of market complaints with complaint sample (If provided by complainant) and control sample, in order to take corrective and preventive actions.
- To handle various audits as front line auditee and compliance the NCs raised in the audits.
- Coordination with internal and external customers, like QA, RA, R&D; and different instrument vendors.
- Team handling- capable to handle a team of 20 analyst and planning of analysis in shifts.

📌 Sr Manager Manager QC Stability Section (Pune)
🏢 Agio Pharmaceuticals
📍 Pune