Senior Specialist - Quality

Merck & Co., Inc.

Unknown, Unknown, Argentina
Hybrid
10 years experience in change control
Cgmp compliance knowledge
Analytical standards management
The role involves providing functional support for Analytical Standards and managing analytical change control activities across a global manufacturing network

Job Summary

  • The role involves providing functional support for Analytical Standards and managing analytical change control activities across a global manufacturing network.
  • Candidates must ensure all activities comply with regulatory requirements and current Good Manufacturing Practices (cGMP) while coordinating with stakeholders in Regulatory, Technology, and Supply Chain.
  • The position requires maintaining active ingredient and final product Analytical Standards and participating in compendial update implementations.

Matching Summary

The role involves providing functional support for Analytical Standards and managing analytical change control activities across a global manufacturing network.

Skills & Requirements

Must-have

  • 10 years experience in change control
  • cGMP compliance knowledge
  • Analytical standards management
  • Compendial compliance expertise
  • Document review and approval

Nice-to-have

  • Strong collaborative communication skills
  • Advanced problem solving abilities
  • Creative thinking and resourcefulness
  • Ability to build consensus
  • Proficient computer skills

Key Requirements

  • BS degree in life sciences or engineering
  • Minimum 10 years professional work experience
  • Experience in laboratory operations or quality oversight

Work Rights

Not specified

Tailored Resume

Cover Letter