Quality Systems Specialist (m/f/o)

Tasks

• Support the development, control and continuous improvement of quality principles in line with internal quality requirements and GMP guidelines, including cGMP, ICH and 21 CFR
  
• Manage and maintain the company’s documentation system, ensuring effective control of SOPs, forms, the Site Master File, analytical methods and batch records
  
• Manage and maintain the company’s electronic systems, ensuring compliance with Computer System Validation (CSV) requirements
  
• Participate in risk assessments related to ongoing site operations
  
• Lead and participate in the Site Internal Audit Programme
  
• Coordinate and manage client and regulatory audits conducted at the site
  
• Oversee the management of the site’s archiving system
  
• Collaborate across departments to support regulatory compliance and process improvements

Requirements

• Post-secondary qualification in life sciences or a related field; a degree in life sciences is preferred
  
• Previous experience in a pharmaceutical quality systems environment is considered an asset
  
• Good understanding of GMP guidelines, including cGMP, ICH and 21 CFR
  
• Proficiency in Microsoft Office applications
  
• Familiarity with electronic management systems such as TrackWise and LabWare
  
• Excellent written and verbal communication and interpersonal skills
  
• Strong attention to detail and analytical and problem-solving abilities
  
• Ability to identify solutions and implement effective methods and procedures
  
• Strong organisational skills with the ability to manage multiple projects, duties and assignments simultaneously