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Job Description
Quality Assurance Specialist responsible for ensuring compliance with Good Manufacturing Practice (GMP) regulations in a biological and/or pharmaceutical industry setting.
This role involves carrying out tasks and projects related to Quality Assurance activities, including:
• Incoming material release and batch release
• Change control and event management
• Supplier qualification and annual product review
• Validation compliance activities
• Administration of event management systems, batch records, and SAP Quality Management Module
• Site change control systems and validation activities
• GMP audits and on-site walkdowns
• Supplier approval process
Key Skills and Competencies:
• Excellent interpersonal and communication skills
• Ability to operate as part of a team
• Customer focus and innovative thinking
• Attention to detail and good problem-solving skills
• Results-driven and adaptable
Qualifications and Experience:
• Bachelor's Degree in a scientific/technical discipline
• Minimum 3-5 years experience in a quality, validation, or compliance role
• Knowledge of FDA/EMEA regulatory requirements
• Ability to apply GMP regulations and industry guidelines