LIMS QC Deputy MANAGER
Job Description
Sr. No.
Responsibilities
1.0
Work allocation for LIMS Department.
2.0
Review Documents in LIMS Software for All location
2.1
Review of Finished product , Raw Material and In process Specification, MOA and worksheet In LIMS
2.2
Preparation, Review and Revision of Packing material Specification, MOA and worksheet.
2.3
Create Assay master, Market master and test characteristic In LIMS
2.4
Operation and Handling of LIMS Software.
2.5
Transfer Raw Material/ Finished product specification, MOA and Worksheet from Plant to Plant in LIMS.
3.0
Handling of QMS Activity
3.1
Change control initiate/Review as per Pharmacopoeial changes, during periodic review and as per stake holder requirement and Impact assessment for change control
3.2
Handling of Deviation and CAPA
3.3
Risk Assessment Preparation/Review for SOP/STP/SPEC/MOA whenever it is required.
4.0
Others
4.1
Handling of Pharmacopoeial changes and Intimation Review for any changes.
4.2
Review Finished products/ In process/Raw materials/ Packing material Reference for prepared and revised Spec/MOA.
4.3
Maintenance and Record of LIMS document.
4.4
PQ activity performed / Reviewed as and when required
4.5
Preparation and revision of SOP /STP as and when required
4.6
Provide Training to new joinee for LIMS
Sr. No.
Responsibilities
5.0
Co-ordinate with LIMS vendor for trouble shooting of LIMS related issues
6.0
Intimation to CQC head for any abnormal observation.
7.0
SOP Harmonization Activity / Compliance Activity
8.0
Any other responsibility may be assigned from time to time.
9.0
Preparation and review of AMV protocol and reports.