1. JOB PROFILE
KAILASH CHOUBEY
+91 8803722093 Vill- Bhupatipur
8894670699 Post- KarawatahiBazar
Dist- Gopalganj
Choubey_kailash@yahoo.com State- Bihar
kailashpharmaqms@yahoo.com Pincode- 841501
choubey07kailash@gmail.com (Mo):- +91 9862224007
QA- 4.6 years Experience (B.Pharm.)
Page | 1
JOB PROFILE:-
Shop Floor Activity :- Dec 2011 to May 2015
 Givingline clearance asperthe SOPand GMP.
 Givingapproval of packingmaterial as Per Batch Packing Record or as perStandard
Packing MaterialSpecifications.
 Monitoring the environmental condition of the plant.
 Monitoring the floor cleaning and maintenance of machines and equipments.
 Responsible for periodic calibration of in-process equipments.
 Usage of log book.
 Issuance of Quality Assurance Inspection Report.
 Release of Finished Goods Transfer Slip.
 Maintaining and updating the records of IPQA documents.
 To do the Inprocess and Process checks of the Compression, Coating, Granulation and
Verifying and Cross checking the Dispensing of Raw Material and Packing Material.
 Checking, issuance and review of BMR and BPR .
 Handling of NCR and maintenance of records.
 Reporting Non-conformance to QA Head.
 Sampling of various Inprocess and Finished product.
 Rinse water sampling and analysis of the same.
 Swab sampling and its analysis through UV Spectrophotometry
 Carrying out Process Validation as per the Protocol.
DOCUMENTATION: QMS (May-2015 to till date)
 Handling of Deviation. Assigning Deviation No., maintaining its log,
compilation of supporting data w.r.t nature of Deviation, and its investigation with
investigation team.
 Handling of Change Control: - Issuing change control to initiator department
with change control No., assessment, evaluation and monitoring of changes as
proposed. Review of comments, impact analysis and action plan related to the
proposed change.
 Handling of Market Complaint: - Maintaining records of Market complaint,
filing the complaint, assigning complaint No., Its investigation and assigning
proper root cause in consultant with Head- QA. Compilation and preparation of
investigation report. Replying against the complaint to respective customers after
approval from Plant Head and QA- Head.
 Handling of Non-Conformance/Incident: - Preparation of Non –Conformance
report, maintaining its record and reporting the same to QA- Head.

2. JOB PROFILE
KAILASH CHOUBEY
+91 8803722093 Vill- Bhupatipur
8894670699 Post- KarawatahiBazar
Dist- Gopalganj
Choubey_kailash@yahoo.com State- Bihar
kailashpharmaqms@yahoo.com Pincode- 841501
choubey07kailash@gmail.com (Mo):- +91 9862224007
QA- 4.6 years Experience (B.Pharm.)
Page | 2
 Managing CAPA System:- Issue of CAPA form, assigning CAPA No.,
Verification of proposed CAPA as well as CAPA taken, compilation of all
supporting data related to CAPA, to review and check the effectiveness of CAPA
till its successive closure.
 Handling of OOS/OOT/OOE: - Assigning tracking No. to the Out Of
Specification reported. Investigating detail related to the failure and Root cause
Analysis. Compilation of report, reviewing the sources of failure and submitting
the report to QA Head for final review and approval.
 Root Cause Analysis: - Root cause Analysis using Six Sigma Principle, 5 why
tools, Fish Bone diagram, Is/Is Not Analysis.
 Discharging the duties as per the direction of the Head.
Date: 21/03/2016 Kailash Choubey.
Place: Jammu