S Kant Healthcare Ltd - Urgent Openings in Production / QC / QA / Microbiology
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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