|Company:||NO DEVIATION PTE. LTD.|
• Responsible for planning, executing and closing out the validation activities within the assigned area.
• Develop required validation documents, including Risk Assessments, plans, protocols, and reports.
• Apply science and risk based approach into all assigned tasks.
• Review, analyse, interpret and summarise data of executed studies.
• Investigate or support the investigating of deviations or non-conformities raised during validation studies.
• Provide SME input wherever required.
• Ensure safety, quality and delivery of the validation projects.
• Effectively collaborate with all identified stake holders. Wherever required, collaborate with Global/Corporate functions.
Required Experience & Knowledge
• Minimum Bachelor’s degree in science or engineering discipline
• Minimum 5 years of experience in pharmaceutical CQV.
• In-depth knowledge in the assigned area and of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
• Fluency in written and spoken English
• Ability to work in a fast paced / dynamic work environment
• A fast learner with “Can-do” attitude
• Good time management skill and great attention to detail.
• Proficient presentation and facilitation skill is a plus.
EA License No : 19C9587
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