Clinical QA Systems, Documentation Specialist

• Responsible for the life cycle management of R&D and Clinical documents according to company SOPs

• Participate in the implementation of new systems or improvements to existing systems

• Administer the clinical trial documentation system in compliance with regulations and procedures

• Responsible for maintaining and developing training profiles and documentation for Clinical departments

• Bachelor' s degree in scientific or related field
• Typically requires minimum of 5 years of experience with document systems within a Quality Organization or related area in the Biologics, Biotech or Pharmaceutical industry
• Good Knowledge and understanding of quality and regulatory requirements for the biotechnology and pharmaceutical industry
• Familiarity with quality systems and compliant maintenance of quality-related documentation and records, including knowledge of electronic document control systems
• Proficient in word processing and spreadsheet applications
• Ability to prioritize competing tasks and meet deadlines to ensure compliance
• Excellent oral and written communications skills and the ability to work in a cross-functional and multi-cultural team environment

• document systems
• quality systems
• electronic document control systems
• word processing
• spreadsheet applications

• ability to prioritize tasks
• meet deadlines
• oral communication skills
• written communication skills
• teamwork

• Bachelor's degree