drjobs Senior Officer, Analytical R&D Compliance

Senior Officer, Analytical R&D Compliance

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1 Vacancy
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Job Location drjobs

Ahmedabad - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Description

Below is the JD for GLP Position :

  1. To perform / review daily calibration of laboratory equipment lamp energy check time synchronization check temperature monitoring and any compliance related activities.
  2. To maintain laboratory equipment in proper operating condition and perform calibration as required after completion allied training of sophisticated instruments i.e. UPLC HPLC GC ICP-OES ICP-MS Dissolution Apparatus etc.
  3. To deliver consistent and precise results by following safety and GXP protocols/ SOPs/ regulatory guidance.
  4. To associate service/instrument engineer during routine preventive maintenance and troubleshooting/repair services on all laboratory equipment.
  5. To establish execute and evaluate laboratory instrument calibration procedures and policies.
  6. To prepare qualification protocol / report and compliance documents.
  7. To prepare and execute the Computer Systems Validation protocols and to make sure that all GxP computer-based systems are operating as intended and meet regulatory requirements.
  8. To interact with Quality Assurance and service providers other cross functional department related to CSV Qualification and PM activity.
  9. To prepare / revise Standard Operating Procedures through change control procedure in accordance to regulatory guidance / reference documents.
  10. To update lab compliance documentation system to exceed good laboratory practice nearly meeting site GXP quality standard expectations.
  11. To create update review and manage of Calibration Preventive maintenance and validation schedule.
  12. To review Third-Party Documents / Certificate of Analysis.
  13. To receive and manage controlled issued documents from QA Department.
  14. Issuance of Laboratory notebook Equipment logbook and Column usage registers.
  15. To qualify in-house Working / Reference standard and impurities.

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Required Experience:

Senior IC

Employment Type

Full-Time

Company Industry

About Company

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