S Kant Healthcare Ltd - Urgent Openings in Production / QC / QA / Microbiology - Apply Now - PHARMA WISDOM

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Saturday, 23 May 2020

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


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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