Senior Executive Quality Assurance
Job Location:
Monthly Salary:
Posted on:
Vacancies:
Job Summary
JOB DESCRIPTION:
Followings will be the responsibilities of the position holder:
1. Preparation and review of qualification and Validation documents (URS DQ IQ OQ PQ etc.) for ODF Facility.
2. Preparation and updation of Validation Master Plan CVMP SMF Quality Manual and planner for ODF facility.
3. Execution of qualification and requalification activities for ODF facility.
4. To review plant layouts and drawings for ODF facility.
5. To perform decommissioning study of equipments for ODF facility.
6. To perform activity in software Darius ISOtrain and SolTRAQ for ODF facility.
7. Co-ordination with other departments for streamlining qualification activities for ODF facility.
8. Execution of process validation protocols for ODF facility.
9. Monitoring of calibration activities and review of related documents.
10. Preparation of SOP training modules on validation and execution of training sessions for ODF facility.
11. Review of Calibration and Preventive maintenance related documents.
12. Execution of Qualification/Validation activity for critical utilities e.g. compressed air nitrogen HVAC/area validation Purified Water.
13. Preparation execution of documents related to computer system validation for ODF facility.
14. Perform QRM for qualification activities for ODF facility.
15. To initiate and review the change control activity for ODF facility.
16. Implementation of new regulatory and Abbott guidance / EQDs related to qualification.
17. To ensure compliance of qualification activities as per Abbott EQD and AQ requirement
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
India > Village Mauza : Baddi
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Required Experience:
Senior IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
