Specialist, Tech Ops Control Operations

alvotech.is

Not specified; not specified; excellent in-house c...
**
Cgmp standards adherence
Deviation investigation experience
Capa and change control ownership
** Alvotech is seeking a Control Operations Specialist to support its biomanufacturing quality operations, ensuring compliance with cGMP standards. The ideal candidate should have a background in compliance roles within biomanufacturing and a strong dedication to quality and continuous improvement in a dynamic work environment. **

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 improvement across the production environment.
  • Alvotech offers an inspiring challenge with a global, fast-growing culture that encourages diversity, collaboration, and personal growth.

Matching Summary

Match Score: 75

** Alvotech is seeking a Control Operations Specialist to support its biomanufacturing quality operations, ensuring compliance with cGMP standards. The ideal candidate should have a background in compliance roles within biomanufacturing and a strong dedication to quality and continuous improvement in a dynamic work environment. **

Salary

Not specified; Not specified; Excellent in-house canteen, coffee house, exercise support, on-site shower, transportation grant, home internet

Skills & Requirements

Must-have

  • cGMP standards adherence
  • Deviation investigation experience
  • CAPA and change control ownership
  • Biomanufacturing compliance oversight
  • Facility risk assessment skills

Nice-to-have

  • DP operations knowledge
  • Problem-solving in dynamic settings
  • International regulatory agency interaction
  • Pre-Approval Inspection support
  • Commitment to diversity and inclusion

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 working with international regulatory agencies including FDA and EMA

Work Rights

Not specified

Tailored Resume

Cover Letter