Job Description

JOB DESCRIPTION:
Education Qualifications:
MSc/B.Pharm/M.Pharm
Work Experience (Total number of years/ experience/ background or equivalent):
Total experience (in years): 10
Experience in current role (in years): At least 02 Years
Work Background: GxP Audit and compliance
Primary Job Function & Core Job Responsibilities:
To perform supplier audits for Raw and Packaging material in case of new, alternate and existing suppliers as per the schedule.
Review and finalization of supplier management SOP in accordance with current EQD quality directives applicable to supplier quality management.
Participation in vendor development project.
To monitor all Corrective and Preventive Actions related to the audit findings are implemented appropriately and as per the defined timelines.
To perform for cause supplier audits as per the need and assess the CAPA to avoid further recurrence of the same.
To perform risk assessment for suppliers, post caution/unsatisfactory audit outcome/Audit schedule overdue etc.
To update Audiq & Material service grid in the system.
To Audits of CFA/Warehouse.
To provide support to Abbott Manufacturing sites located in India for audit readiness.
Coordination, evaluation and completion of supplier change notification.
Support for supplier complaints/quality issues are addressed with appropriate CAPAs in place.
Review of QQ and Technical document package for new and alternate vendor development
Provide support for updation and maintenance of ASL.
Complete auditee and audit documentation in AudiQ system
The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Operations Quality
DIVISION: EPD Established Pharma
LOCATION: India
Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: No
MEDICAL SURVEILLANCE: No
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)