ASSISTANT MANAGER

Department Details

BPL QA

Role Summary

In-Process Quality Assurance (IPQA-OSD)

Key Responsibilities

The person with hands on IPQA experience will be considered.

• To follow the GMP & GDP practices in daily production activities.

• Responsible for Calibration or verification of IPQA instruments.

• Performing the in-process Quality checks and cleaning of sampling aids.

• Responsible for providing the Line clearance certification.

• Online review of batch record at all stages of manufacturing and packing activities.

• Sampling of in-process, process validation, cleaning validation, hold time, finished product, stability sample and retention samples.

• Review and release / rejection of batch at in-process, intermediate and finished product stages of manufacturing of drug products and ensure the batch release or rejection SAP.

• Preparation, review and approval of Process validation/optimization/ Hold time protocol and report.

• Responsible for initiation and review of Change control/Deviation/ CAPA

• Responsible for Preparation and review of APQR

• Responsible for Review and approval of Production & Warehouse SOP's

• Responsible for tracking of external calibration of IPQA Instruments

• Performing equipment challenge test during process validation and batch execution

Educational Qualifications

Required Education Qualification:
Required Experience: 8 - 10 years