Specialist, Tech Ops Control Operations

Alvotech

**
Cgmp standards adherence
Deviation investigation and handling
Capa and change control management
** Alvotech is seeking a Control Operations Specialist to support quality operations in biomanufacturing, ensuring compliance with cGMP standards and contributing to continuous improvement in production. The ideal candidate should thrive in a dynamic environment, enjoy problem-solving, and have a strong background in regulatory compliance within biomanufacturing. **

Job Summary

  • The role involves supporting key quality operations within biomanufacturing while ensuring strict adherence to cGMP standards.
  • Candidates will be responsible for initiating investigations, managing deviations, and driving continuous improvements across the production environment.
  • Alvotech offers an inspiring challenge with a global, diverse work culture focused on improving lives through affordable biologics.

Matching Summary

Match Score: 75

** Alvotech is seeking a Control Operations Specialist to support quality operations in biomanufacturing, ensuring compliance with cGMP standards and contributing to continuous improvement in production. The ideal candidate should thrive in a dynamic environment, enjoy problem-solving, and have a strong background in regulatory compliance within biomanufacturing. **

Skills & Requirements

Must-have

  • cGMP standards adherence
  • deviation investigation and handling
  • CAPA and change control management
  • biomanufacturing compliance oversight
  • facility risk assessment review

Nice-to-have

  • problem-solving in dynamic settings
  • continuous improvement mindset
  • international regulatory agency experience
  • DP operations knowledge
  • collaborative team player

Key Requirements

  • Minimum 3 years in compliance role for biomanufacturing
  • Degree/Diploma in related discipline or sufficient relevant experience
  • Knowledge of FDA, ICH, PIC/s regulatory guidelines
  • Experience supporting Pre-Approval Inspections (PAI)

Work Rights

Not specified

Tailored Resume

Cover Letter