Team Member - QC

Job Description

Roles & Responsibilities:

1.1 Responsible for Entry and Exit procedures in QC-Department.

1.2 Responsible for GMP / GLP/ GDP and safety Compliance.

1.3 Ensuring and maintaining good housekeeping in the lab.

1.4 To ensure proper Handovering of the shift.

1.5 Stability protocol preparation, stability analysis and execution

1.6 Handling of stability chambers and maintenance.

1.7 Stability data sheet preparation and compilation

1.8 Daily chamber reports print taking & review.

1.9 Preparation of monthly & yearly master schedule for stability.

1.10 Responsible for loading and withdrawal of stability samples for intermediate &API.

1.11 Analysis of Inprocess, RM, PM, Intermediates, API, working standard qualifications and stability samples, Experimental samples from Process R&D& Method transfer.

1.12 Preparation and Review of QC related protocols and batch related protocols.

1.13 Analysis of Raw materials, In process, Intermediates, API, working standard qualifications and stability samples and Calibration of HPLC

1.14 To operate the instruments of their respective SOP’S.

1.15 To ensure whether the instrument is calibrated or not before start of the analysis.

1.16 To carry out the analytical tests as per the related SPEC and MOA’S.

1.17 Handling of incidents, OOS and OOT.

1.18 Carrying out investigations and preparation of investigation reports and impact assessment.

1.19 Ensuring the sampling from the analyst and weighing procedure for sampling.

1.20 Issuing the Work order & Breakdown for necessary works in QC lab.

1.21 Intimation to engineering team regarding Work orders in QC.

1.22 Responsible for handling of documents and Waste labels in Drop box.

1.23 Responsible for CAPA closure.

1.24 Handling of materials through isolator in HPAI QC.

1.25 To undergo the training assigned in LMS.

1.26 COA Preparations for Dispatch Purpose& typical COA preparation for Regulatory Affairs submission.

1.27 Responsible for CCF initiation and action plans closure.