Senior Manager Tpm Qa

Abbott

Mumbai, India
Tpm site oversight for compliance
Gmp aspects and abbott policies
Quality agreements with tpms
Oversight of assigned TPM sites for Product, Site & Quality compliance, leading and guiding teams on GMP aspects and Abbott policies and procedures

Job Summary

  • Oversight of assigned TPM sites for Product, Site & Quality compliance, leading and guiding teams on GMP aspects and Abbott policies and procedures.
  • Ensure Quality Agreements are in place with TPMs, assess site performance, and ensure Pharmacopoeial compliance of Abbott products manufactured at sites.
  • Recruit, mentor, train, and develop TPM QA India team members while managing stakeholder expectations and supporting various projects.

Matching Summary

Oversight of assigned TPM sites for Product, Site & Quality compliance, leading and guiding teams on GMP aspects and Abbott policies and procedures.

Skills & Requirements

Must-have

  • TPM site oversight for compliance
  • GMP aspects and Abbott policies
  • Quality Agreements with TPMs
  • Pharmacopoeial compliance
  • Market complaint investigation
  • Regulatory changes impacting products

Nice-to-have

  • Leverage knowledge and networks
  • Out of the box thinking
  • Flexible, proactive, and motivated
  • Collaborative work style
  • Adaptable in high-pressure environment
  • Intercultural competence

Key Requirements

  • 20 years of experience
  • NPI, QC/QA, QMS, R&D QA, TPM Management, Tech Transfer, Dossier review, Due Diligence
  • Managed TPMs in significant capacity
  • Knowledge of Latam, APAC, EU regulations
  • B Pharm /M. Pharm / Master in Science

Work Rights

Not specified

Tailored Resume

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