Assistant Manager-QC

Key Responsibilities:

•  Responsible to ensure good housekeeping in the QC Laboratory.

•  Responsible to ensure Laboratory Compliance verification w.r.t. GDP/GLP and cGMP.

•  Wear proper PPE and follow safety rules precisely in the Laboratory.

•  To Review the routine analysis, Analyst Qualification/Re-Qualification, Reference/Working standard Qualification/Re-Qualification and instrument calibration/Qualification documents.

•  Allotment of work to the team member’s w.r.t. reviewing of Raw materials, packing materials, Intermediates, Finished, Stability and water samples documents.

•  Authorized to approve/Reject the materials/products.

•  Create & edit the methods & monthly projects in analytical instruments.

•  Supporting to preparation of Investigation reports in the event of OOS, OOT and deviations.

•  Review of Cleaning, Process validation, instrument qualification and Method Validation/transfer/verification Protocols and Reports.

•  Project and System Audit trail Review for Empower related systems.

•  Responsible for co-ordinate with CFT for smooth functioning related to review of analytical documents.

•  Prepare and review the SOP’s, STP’s.

•  Ensure the completion of trainings related to validation studies, CAPA, SOJT/SGMP to the team members.

•  Responsible to ensure that all laboratory activities are being carried out as per the documented procedures. 

•  Assisting to Head of the department for all QC related activities.

•  Reporting the departmental activities to immediate Head of the Department/Designee

Key Competencies (Technical, Functional & Behavioral)

Technical & Functional:

•  Good communication skills

•  Demonstrate ownership and collaboration at work.