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Multiple Job Openings at S Kant Healthcare Ltd | M.Sc, M.Pharm, B.Pharm

academics

 

Clinical research courses

S Kant Healthcare Ltd. is the formulations division of the SK Group, serving the pharmaceutical industry since 1932. Acquired from M/s. Solvay – Duphar (Holland, EU) in 1996, this mammoth multi faceted manufacturing facility is spread across 11 acres (Approximately 45,000 sq. meters). Having dedicated buildings for manufacturing of Formulations, APIs, Metallic Stearates , Herbal Extracts, it is truly a World Class Layout in one of India’s largest and finest industrial zones at Vapi, Gujarat. Easily connected by Air, Sea, Road & Rail the geographic location is ideal for serving both domestic and international markets.

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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