Head – TPMQA India - Biosimilars

JOB DESCRIPTION :

Primary Job Function : TPM's supplying to Biosimilars in India and APAC region

• Quality Oversight of TPM's
• QMS Management at TPM's
• Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility
• Investigations of Products failures, OOS, Complaints pertaining to Abbott products
• Review of APQR's
• GMP compliance at TPMs.
• Compliance to Abbott procedures and policies.

Core Job Responsibilities :

Supervisory / Management Responsibilities :

Direct Reports : 00

Indirect Reports : 00

Position Accountability / Scope :

Minimum Education :

Minimum Experience / Training Required :

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 : Not specified

MEDICAL SURVEILLANCE :

Not Applicable

SIGNIFICANT WORK ACTIVITIES :

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Skills Required

regulatory audits