Change control manager (GMP-pharma)

Basic requirements:

• Scientific academic background, preferably in pharmacy, biology or chemistry
• Sufficient experience in the pharmaceutical industry in R&D, QA, production, RA
• Well organized person and capable of managing multiple projects, excellent time management with respect to priorities and self-management
• Ability to work pro-actively 

Job Description:

• Provide administration of change management
• Drive and coordinate all product related changes (with or without regulatory relevance) and maintain relevant data
• Ensure timely implementation of all on-going product life-cycle activities
• Liaise with country managers, regulatory affairs department, business process owners and clients to facilitate working out and implementation of changes
• Participate in preparation, reviewing and issuing production, QA, QC, registration documentation
• Actively support in addressing health authorities deficiency letters
• Cooperation and support in quality inspections/audits including their follow-up actions
• Provide investigation of compliance related deviations
• Implementation of quality improvement projects