Cleaning Validation Analyst
Il y a 2 jours
PuursSintAmands, Flanders, Belgique
DPS Group Global
Temps plein
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As a Cleaning validation Analyst you will be responsible for the planning, execution and reporting of studies/tests related to cleaning validation and risk assessment:
• Providing crucial support to both operational and project teams for cleaning validation initiatives, which includes drafting protocols and reports, scheduling and executing routine cleaning qualification studies, and analyzing results
• Ongoing support of marketed drug products by assisting with the practical preparation, execution, and reporting of cleaning validation for planned product/process changes
• Lifecycle management
• Investigation of quality issues
• Proactive monitoring of product quality by ensuring effectiveness
• Compliance of cleaning processes
Qualifications:
• Bachelor's degree in industrial, civil, or bio-engineering, or industrial pharmacy, or demonstrate equivalent experience
• Essential qualifications include good social and organizational skills, including the ability to work effectively as a team player
• Proficiency in PC software applications is necessary
• Perfect command of both Dutch and English
• Good technical writing style
• Strong problem-solving ability, including a degree of creativity to address deviations and suggest improvements
• Strong interpersonal skills and the capacity to work organized and accurately
• Flexibility to work in a two-shift system (6am-2pm and 2pm-10pm)
• Prior experience in similar projects and within a GMP environment is considered an advantage
• Providing crucial support to both operational and project teams for cleaning validation initiatives, which includes drafting protocols and reports, scheduling and executing routine cleaning qualification studies, and analyzing results
• Ongoing support of marketed drug products by assisting with the practical preparation, execution, and reporting of cleaning validation for planned product/process changes
• Lifecycle management
• Investigation of quality issues
• Proactive monitoring of product quality by ensuring effectiveness
• Compliance of cleaning processes
Qualifications:
• Bachelor's degree in industrial, civil, or bio-engineering, or industrial pharmacy, or demonstrate equivalent experience
• Essential qualifications include good social and organizational skills, including the ability to work effectively as a team player
• Proficiency in PC software applications is necessary
• Perfect command of both Dutch and English
• Good technical writing style
• Strong problem-solving ability, including a degree of creativity to address deviations and suggest improvements
• Strong interpersonal skills and the capacity to work organized and accurately
• Flexibility to work in a two-shift system (6am-2pm and 2pm-10pm)
• Prior experience in similar projects and within a GMP environment is considered an advantage