Career Opportunities: Manager - Quality Control (32004)
Requisition ID 32004 - Posted - External - India
Position:
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Manager I
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Job Title:
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Job Grade:
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G10
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Function:
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Quality Control
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Sub-function:
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Raw Material
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Manager’s Job Title:
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Skip Level Manager’s Title:
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Function Head Title:
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Sr.Manager-1
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Location:
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Dadra
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No. of Direct Reports (if any)
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13
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Job Responsibilities
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- Planning and analysis monitoring of Raw material/ Retest material and interaction with Production and Ware house Department.
- Monitoring of volumetric solution and general reagents including documentation as per respective SOP.
- To participate in the laboratory failure investigation / OOS / OOT/ Unplanned Deviation /Lab event, root cause identification and its appropriate corrective action, correctiveness of Hypothesis performed, correctiveness of Impact analysis, verification of implementation of effectiveness of CAPA in QC Dept.
- Planning and monitoring of sampling activity carried out at Dadra-I and Dadra-II.
- Monitoring of Control sample and Out lab testing Activity.
- Evaluation and implementation of Pharmacopoeial changes.
- Planning of analysis for Working Standard.
- Planning and monitoring of Vendor sample analysis.
- Responsible and accountable for sample management in the Raw Material Material section.
- Handling of QMS activity in trackwise system.
- To execute the Gap Assessment related to Raw Material section.
- Effective monitoring of RM section analyst productivity as per business requirement.
- To conduct training as per need based on CAPA/ OOS/ OOT/ Lab event and as per revised or new SOP.
- Co-ordination for document submission required by RA.
- To impart training to RM Section analyst related to method and techniques provided in ATP.
- To provide the inputs required for weekly/ monthly report preparation.
- To report immediately if any abnormalities observed during analysis of RM section.
- To ensure availability of column, reagent, working standard, reference standard, impurity standard for Raw material analysis.
- To ensure the revision of SOP, Specification, ATP and Template required for RM section.
- To ensure the effective cleaning procedure is being followed in Sampling and Sampling devices at Dadra-I and Dadra-II.
- To track and monitor compliance related to RM section.
- To monitor cleaning and upkeep of QC laboratory.
- Participation in review & approve of SOP in EDMS.
- To ensure laboratory cleanliness and orderliness.
- To ensure the laboratory safety and personal hygiene in lab.
- To check & follow the GLP standard in the laboratory
- To follow GDP and GMP requirements on the routine basis
- To follow and ensure the compliance related to Data Integrity.
- EDMS forms Reconciliation:
- Track, Monitor and reconcile EDMS forms before it's due date.
- Take extension of Forms due for retrieval in EDMS in case if activity not completed
- To perform any other additional activity assigned by Department head.
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