Job Description
JOB OBJECTIVES
Ensure compliance, scientific rigour and efficiency in the validation of processes, equipment/system,
cleaning and computerised systems, in accordance with regulatory requirements (GMP, FDA, EMA,
HC, etc.) and company quality standards.
PRIMARY FUNCTIONS
• Supervise the team of validation specialists (participate in recruitment, manage performance,
conduct performance reviews, etc.).
• Ensure compliance, scientific rigour and efficiency in the validation of processes, equipment,
computerised systems and analytical methods, in accordance with regulatory requirements (GMP,
FDA, EMA, HCC, etc.) and company quality standards.
• Technical supervision: Lead a team of validation specialists (processes, equipment, cleaning,
computerised systems) and ensure their skills development.
• Regulatory compliance: Supervise validations in accordance with GMP, FDA 21 CFR Part 11,
ICH Q7/Q9/Q10, and interna...
Ensure compliance, scientific rigour and efficiency in the validation of processes, equipment/system,
cleaning and computerised systems, in accordance with regulatory requirements (GMP, FDA, EMA,
HC, etc.) and company quality standards.
PRIMARY FUNCTIONS
• Supervise the team of validation specialists (participate in recruitment, manage performance,
conduct performance reviews, etc.).
• Ensure compliance, scientific rigour and efficiency in the validation of processes, equipment,
computerised systems and analytical methods, in accordance with regulatory requirements (GMP,
FDA, EMA, HCC, etc.) and company quality standards.
• Technical supervision: Lead a team of validation specialists (processes, equipment, cleaning,
computerised systems) and ensure their skills development.
• Regulatory compliance: Supervise validations in accordance with GMP, FDA 21 CFR Part 11,
ICH Q7/Q9/Q10, and interna...
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