Hiring QA Process Validation, Cleaning validation DM Nagpur OSD PLant

4 days ago

Nagpur, Maharashtra, India Select Source International Full time ₹ 20,00,000 - ₹ 25,00,000 per year
  • Department Quality Assurance
  • Section Documentation
  • Designation Deputy Manager
  • Qualification M.Pharmacy / B.Pharmacy
  • EXP Required 12 Years
  • Reporting to Sr. Manager

Sr. No.

Responsibility

Responsible for Preparation, Review of Process Validation, Cleaning validation protocol & reports.

2

Responsible for Execution of Process Validation, cleaning validation activity.

3

Responsible for Preparation. Review of hold time study protocol & reports, Execution of hold time study against planner.

4

Responsible for Preparation of Standard operating procedure.

5

Responsible to provide Personal training.

6

To ensure complete documentation, control and retention of validation documents against activity done.

7

To review of Technology transfer documents.

8

Participation in internal inspection, external audits, customer audits & ensure availabilities of all the documents during audits & its compliance.

9

Responsible for review of equipment qualification & re- qualification documents & monitoring of the activity during execution.

10

Responsible for continuous process verification.

11

Responsible for review of computerized system validation protocols, reports & monitoring of computerized system validation activities.

12

Responsible to monitor calibration activities, temperature mapping activities against earlier activities carried out

13

Responsible to participate in quality risk management.

14

Responsible for preparation of Validation Master Plan.

15

Responsible to monitor water system validation activities against planner.

16

Responsible for review of area qualification & re-qualification documents & monitor execution activities.

17

Responsible for HVAC qualification & re-qualification documents and monitor execution activities.

18

Responsible for review & monitor the utility validation/ qualification activities.

19

Responsible for planning & execution of non-routine validation studies.

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