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Quality Assurance Executive

Komal Healthcare Pvt Ltd
Mumbai Posted: 1 week ago No. Of Positions: 1

Job Description

Operations:
Testing of Raw Materials:                                                     
•    Receiving the testing status from QC and giving Ar.No. to raw material.
•    Suggesting improvements to company infrastructure and processes to prevent future mistakes during production
•    Reporting discovered defects to all relevant departments for correction
Testing to Intermediate products:
•    Coordinating with the manufacturing department in controlling their process and products to meet the specification through testing auditing and reports.
•     Assessing whether employees need training to prevent mistakes during production.
•    Samples to be collected by IPQA for testing to ensure the quality of the product during the manufacturing process.  
•    Inspecting production machinery and employees to make sure the production process runs smoothly
Testing of Finish Goods:
•    To ensure that the final product is defect free and it meets the customer’s requirement standard and specification. Then batch is release after signing on each box.
•    Pre-dispatch quality assurance
Outsource:
•    Sending sample for testing (ortho)
•    Preparing the document for third party sterilization
•    Receiving the sterile samples from store and sending them for sterility testing.
Teaching to subordinates:

•    To ensure that employees working in QA department are aware of quality requirement & standards. Also Responsible for providing training regarding testing procedure etc.
•    Providing training to workers as per quality standards.
•    Representing and guiding to line leaders and operators with respect to production and Quality.
•    Housekeeping audit to be taken and report to be made according to it.
Documentation:
•    Taking care of QA/QC documents of the entire process including certificates, BMR & BPR, calibration, test reports, inspection reports, non-compliance reports and observations, and other QA/QC documents. Responsible for the closure of Non-conformance. Making CAPA (corrective action / preventive action) for rejections.
•    Keep all equipments calibrated & in proper condition. Also maintaining and controlling calibration records for all test and inspection equipment.
•    Recording any events occurs during manufacturing, testing or documentation of products
•    Maintaining the issue, control, review and retrieval of documents.
•    Responsible for monitoring of stability studies.
BMR and BPR:
•    All data generated during the manufacturing of the product is recorded in a file and kept as a hard copy and soft copy.
•    Reviews the BMR and BPR to ensure that the data entered is legible and if not the take appropriate action as per SOP
  Environmental conditions:
•    To maintain all the essential environmental conditions related to manufacturing as per SOP

Documents required to maintain:    
1.    BMR & BPR
2.    Certificate of Analysis
3.    Gamjee Roll Evaluation
4.    Work Environment Control Record
5.    Rejection Record
6.    Employee Training Record
7.    Accident/First Aid/Sanitization Record
8.    Inspection Reports
9.    Calibration Reports
10.    Applicable standards
11.    CAPA
12.    Register for raw material & in process
13.    Sterilization records
14.    PDQA
Communication:
•    Production Team
•    Stores Team
•    Quality Control Team
Reporting
•    Director

  • Work location : Mumbai
  • Work Mode : WFO
  • Job Requirements :1
  • Educational Qualification : Any Degree

Additional Information

  • Pharmacy License

Walk-in Details

  • Contact Name: Mrunali Patil
  • Contact Number: 9167556101
  • Address:
  • Zenium House; Satya sai industrial estate, dharamkanta; near meera banquet; opposite rachana industries; Bhayandar E, Near Phatak road
  • City: Mumbai
  • State: Maharashtra

Other Details

  • Weekly Working Days: 6
  • OFF Days Comment: Not Updated
  • Salary Type: Monthly CTC
  • Salary : 15000 - 22000

Other Description

  • Industry Type: Hospitals , Healthcare
  • Employment Type: Full Time
  • Role Category: Hospitals , Healthcare

Education

Key Skills

  • Implementation
  • Manufacturing Processes
  • Pharmaceutical Analysis
  • Health and Medicine

About Company

Komal Health Care Pvt. Ltd. a leading manufacturer and exporter of Surgical Dressings, Orthopaedic Implants. Hospital Disposables. Established in the year 2003. Komal Health Care Pvt. Ltd. is an offshoot of Zenium group is into manufacturing of cables and wires. Komal Health Care happened as an initiative to venture into the world of medical products and services. For more information visit www.komalhealthcare.com

Company Info

  • Address :

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