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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