Provide Quality oversight and formal approval for qualification and validation activities
Lead and control the site Validation Program
Ensure regulatory and GMP compliance in the management of validation and qualification processes
Guarantee Data Integrity compliance across all site computerized systems
Support the Quality Management in defining, allocating, and monitoring the budget
Manage personnel in compliance with labor laws, contractual obligations, and workplace health and safety regulations
Implement and oversee risk control measures
Drive continuous improvement initiatives aimed at streamlining validation processes

Bachelor’s or Master’s Degree in a scientific or engineering discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
Minimum 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing environments
Extensive experience in validation and qualification of equipment and systems within cGMP-regulated environments
Strong knowledge of EU and FDA regulatory requirements
Proven background in managing validated/qualified systems
Strong capability to define and execute strategies to effectively manage multiple projects simultaneously
Solid technical problem-solving skills
Excellent teamwork and interpersonal skills

QA Validation, Equipment Compliance Manager

Key skills