Sr Manager Manager QC Stability Section

Agio Pharmaceuticals Limited; Pune District; Sur place; INR 900 000 - 1 200 000; Plein temps

Résumé du poste

Agio Pharmaceuticals Limited in Pune is seeking a QC Lab professional to approve, reject and manage in-process, finished product and stability samples. The role includes daily lab management and allocating analyses to analysts based on competency, and ensuring GLP-compliant analysis on calibrated instruments such as HPLC, UV, IR, GC.

You will review raw data and chromatograms, ensure 21 CFR part 11 compliance, handle CAPA, change control, deviations, OOS/OOT, audits, and coordinate with QA, RA,

Responsabilités

• 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.

Description du poste

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.