Position: – Associate QA

Qualification: – B.S.C or B. Pharma

Experience: – 1 Year/ fresher

Exp. In Particular Industry: – Medical Device/Pharma

Special Skill: – Communication skills

Product/ Technical knowledge: – Medical device and GMP

Job Responsibilities: –

  1. Responsible for document control, review, issue, retrieval & superseding of all SOP related to Manufacturing, Engineering. Warehouse, HR, Plastic section, Quality Control, QA and Purchase Departments respectively
  2. Responsible for preparation and updation of Master Document Index for QA and all other departments.
  3. Responsible for issuance of Production Work Order & Batch Manufacturing Record.
  4. Responsible for issuance of Logbooks, formats & all other controlled documents of all departments as per requirements.
  5. To compile all the documents of final finish product BMR for preparation of Batch Release Certificate & Declaration of Conformity.
  6. Responsible for updation of Batch issuance Logbooks.
  7. To check the GMP Compliance in all the areas.
  8. To ensure all the activities are carried out as per defined SOPs and record maintained in Production Department, Injection moulding & Stent, Packing
  9. To monitor Environmental conditions in Injection Moulding, Production Department & Stent.
  10. In absence, charge shall be handed over to the designee
  11. Any other task assigned by Reporting Manager/Seniors
  12. Functional Reporting shall be as per Departmental organogram

Position: – Microbiologist

Qualification: – M.S.C. Microbiology

Experience: – 2 Year/ fresher

Exp. In Particular Industry: – Pharma

Special Skill: – Testing of Sterility, BET and its validation.

Product/ Technical knowledge: – Medical device and GMP

Job Responsibilities: –

  1. Allotting work to Subordinates (Micro).
  2. Monitoring work of subordinates (Micro).
  3. Monitoring of tubes and plates on daily basis.
  4. BET of WFI, PSG on daily basis & Finished products as per schedule.
  5. Testing of stability batches for sterility and BET as per schedule.
  6. Checking of calibration of equipment’s done as per schedule.
  7. To initiate validation of methods in micro as per requirement.
  8. Analysis of raw materials and bulk solutions, Plant water for MLT.
  9. To carry out Validation tests in Micro Lab.
  10. Environmental monitoring of clean rooms (Settle plate, Contact plates, swabs).
  11. Sterility tests of finished batches on daily basis.
  12. Culture Maintenance and its record preparation.
  13. To maintain reports as per Good Microbiological practices.
  14. Preparation of report of the tests performed.
  15. To ensure and maintain cleanliness of micro labs.
  16. To implement GLP & GMP in micro section.
  17. To update any break down in micro section.
  18. Maintaining records of Media, agar, culture and all other standards as used in microbiology.
  19. Maintaining all log books applicable in microbiology laboratory.
  20. Reviewing SOP of micro section as per latest pharmacopeia’s / guidelines.
  21. To impart training to subordinates regarding micro lab.
  22. To ensure that the microbiological analysis are analysed and released within stipulated time period.
  23. Inventory management Media, Culture, Chemicals, Reagents and Glassware.
  24. The work as or when assigned by the superior.
  25. Any other task assigned by reporting managers/Seniors.
  26. Functional Reporting shall be done as per departmental organogram.