RRemoteville
Amandala Neuro logoAmandala Neuro

Quality Compliance Manager

Skills
Data PrivacyData ValidationEasily AdaptableGood Distribution PracticeGoogle Cloud PlatformQIQuality Management
Role

What the job involves

The main requirements, responsibilities and hiring steps.

Requirements

  • Prior experience working with QMS systems covering GCP GVP GMP/GDP
  • Knowledge of computer systems data handling security and data validation
  • Experience reviewing and writing SOPs training mentoring and quality issue tracking
  • Knowledge and experience in quality management and familiar with regulatory procedures and GCP GVP GMP GDP
  • Highly organised with excellent attention to detail and ability to work on own initiative
  • Experienced in computer applications and business software
  • Excellent organisational detailed written and verbal communication skills
  • Ability to be self-motivated and innovative

Nice to have

  • Highly organised
  • Excellent attention to detail
  • Self-motivated
  • Innovative
  • Adaptable

Day to day

  • Support the Head of Quality across all aspects of the Quality Management System in a fast-growing biotech environment.
  • Administer and maintain the electronic QMS including SOP tracking distribution oversight document control and quality issue management.
  • Drive continual improvement by supporting CAPA training inspection readiness vendor oversight and regulatory compliance across GXP activities.