Glp QA

2 weeks ago


Pune, Maharashtra, India UR CFO Consultancy Pvt Ltd Full time
To Maintain copies of all approved study plans and Standard Operating Procedures in use in the test facility.

To verify that the study plan contains the information required for compliance with these Principles of Good Laboratory Practice.

To Conduct inspections to determine if all studies are conducted in accordance with these Principles of Good Laboratory Practice.


To Determine that Study Plans and Standard Operating Procedures have been made available to study personnel and are being followed.

To conduct three types of inspections as specified by Quality Assurance Programme:
Study-based inspections

Facility-based inspections

Process-based inspections

Review of validation of computerised system and data for GLP compliance.

To Maintain records of all inspections conducted.


To Inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies.

To Promptly report any inspection results in writing to Management and to the Study Director.


To Prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates and the dates inspection results were reported to Management and the study director.

To perform audit of study report and raw data.

To verify all processes of archives.

Job Types:
Full-time, Regular / Permanent

Salary:
Up to ₹800,000.00 per year

Schedule:

  • Day shift

Ability to commute/relocate:

  • Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

Experience:

- total work: 3 years (preferred)

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