Openings @ S Kant Healthcare Ltd
QA Officer
Experience: 2-7 yrs
Qualification: B.Pharm /
M.Pharm
Location: Vapi
Job Description:
· Preparation
& Review of Qualification Documents
· Preparation
& Review of SOP's. Preparation of Management Review Report
· Preparation
and Handling of QMS Documents. Handling of Vendor Qualification Documents.
· Handling
of HVAC Re-Qualification activity & review of Documents.
· Handling
of Compressed Air validation activity. Execution of Equipment Qualification
activity.
· Preparation
& review of Validation Master Plan & Site Master File.
· To
review yearly Balance Calibration Reports. To review Preventive Maintenance
Documents.
· To
review Water System Documents. Issuance of all department formats &
logbooks.
· To
Review Calibration Reports.
· To
Review Temperature Mapping Reports. Handling of Market Complaint.
· To
review self inspection Report Ensure the implementation and compliance with GMP
aspects as trained on.
· Ensure
compliance with integrity of data as trained on. To Review batch manufacturing
record & Batch packing records.
· Functional
Reporting & Administrative Reporting to Head QA.
· To
perform and participate regular Self-inspection as per the schedule and
verifying the compliance.
· To
perform Audit of contract laboratory.
Assistant Manager – Production
Experience: 10-15 yrs
Qualification: B.Pharm /
M.Pharm
Job Description:
· Execution
of daily and monthly Production plan.
· Job
distribution to subordinates Job distribution to workmen.
· To
check and receive BMR from QA and issue to raw material stores for dispensing
of raw materials Receipt of dispensed raw material from stores.
· Preparation
of Cleaning solution and disinfectant solution.
· To
check and issue the issued raw materials after taking into the area prior to
issue for production process.
· Generation
of labels of in-process, semi finished and finished products.
· Getting
line clearance from QA before starting the next product.
· Co-ordination
with QC & maintenance department. Troubleshooting related to process and
machine in coordination with Department head.
· Maintenance
of spares inventory Supervision of granulation area, compression, coating and
capsule filling area.
· Monitoring
end point of Granulation, drying temperature and LOD of product.
· Returning
of balance/rejected empty capsule/raw material to raw material store.
· Maintaining
of recoverable recovery and records of the same.
· Monitoring
on production process, In-process checks and changeover time Reporting the
Production Head and QA head for any GMP incidence.
· Investigating
deviations and GMP incidences. On line B.M.R. filling.
· Final
yield reconciliation after each stage before proceeding to next step.
· Performance
check of weighing scale and maintaining records of it.
· Maintaining
Equipment logs of machines. Maintaining record of FBD bags, sifter sieves and
screen of comminuting mail.
· Maintaining
Environmental records. Ensure cleanliness of area, equipment, instrument, FBD
filter bags, filters of risers of AHU, punch and dies Monitoring of
productivity.
· Execution
of production plan as per schedule. Maintaining records of approved semi
finished product store.
· Preparation
of WIP statement of Tablet and Capsule production area.
· Preparation
of reports related to third party work. Workers' attendance and overtime
records.
· Training
of workmen and sub ordinates.
· Preparation
of Purchase requisition and other indents.
· Preparation
of SOP of Granulation.
· Preparation
of Daily production report.
· To
follow the instructions as per SOP, to maintain discipline in the department
and to adhere to GMP requirements.
· To
perform and participate regular Self-inspection as per the schedule and
verifying the compliance.
· To
perform Audit of contract laboratory
QC Chemist / Officer
Experience: 4-5 yrs
Qualification: B.Sc /
M.Sc
Job Description:
· To
follows the current GLP and cGMP in the laboratory.
· To
perform the analytical Method Validation and Analytical Method Verification
· To
perform wet testing of stability samples, semi and finished products.
· To
perform the calibration of Instrument when required. Laboratory temperature
monitoring and its recording when required.
· To
Prepare and standardization of volumetric solution, reagents, and indicators.
· To
perform routine HPLC testing of method validation, method verification,
stability samples, semi and finished products.
· To
prepare the working standard when required.
· To
maintain the chemical and reagent.
· To
perform the Glassware calibration when required.
· Maintain
the all logbook which is used in routine analysis.
· To
review the all logbook which is used in routine analysis.
· To
maintain laboratory discipline.
· Ensure
the implementation and compliance with cGMP.
· Ensure
compliance with data integrity.
· To
perform the routine GC testing, HPLC testing of Raw Material, semi finished,
finished products and Stability samples when required
Microbiologist:
Experience: 4-5 yrs
Qualification: B.Sc /
M.Sc - Microbiology
Job Responsibility:
· To
follows cGLP and cGMP in the laboratory.
· To
ensure good housekeeping and maintenance of cleaning record.
· To
execute the microbiological activities and related documentation.
· To
perform the sampling & testing of water (chemical and microbial analysis).
· To
perform the environmental monitoring of the microbiology lab and production
area and related documentation.
· To
procure and maintain microbial cultures.
· To
prepare and document disinfectants used for regular cleaning and sanitization
of microbiology laboratory.
· To
execute the testing or operating procedure as per current and approved SOP's.
· To
calibrate the Instruments and equipment like pH meter, Conductivity meter,
Balance etc.
· To
co-ordinate with microbiologist in routine analysis.
· To
Intimate and handle the change control, deviation, out of specification & out
of trend. To perform the MLT of raw material, finished product, semi-finished
product, stability samples, packing material samples or any other samples.
· To
perform the analytical method validation of the product and related
documentation.
· To
perform the preservative efficacy test and related documentation.
· To
maintain and review the documents and log books which are used in routine
analysis.
· To
prepare and standardize volumetric solutions, reagents and indicators.
· To
perform bio-assay if required in the sample.
Send CV to hr@skant.com
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