Job Description

As the Senior Associate, Validation under MS&T Team,you will be responsible to maintain the design control of the products and owns the lifecycle management process of the products at site. You will work closely R&D for the transfer of technical documentation relating to design control and risk management review of the products in scope. Ensures seamless flow of knowledge and information across functions, and with other sites when applicable. Responsible for Technical Transfer activities at site level, including any scale-up.

Key Responsibilities

• Oversee team members to ensure efficient task completion and adherence to processes
• Manage production activities, including weigh and dispensing, cleaning, sterilization, and product compounding to meet established specifications, schedules, volume/cost/wastage targets, and quality standards
• Liaise with Materials Management, Engineering, and other departments to develop production schedules and allocate labor/capital resources
• Lead manufacturing investigations, manage product/process non-conformances, CAPA and change control
• Plan, prioritize, and manage production line maintenance and downtime to minimize disruptions
• Lead and deliver continuous improvement initiatives
• Collaborate with cross-functional groups for functional and/or site projects
• Assure a safe work environment and develop pipeline talent
• Foster a culture of excellence by leading performance management, driving talent development, ensuring positive associate relations, enhancing engagement, recognizing achievements, and driving a strong safety culture
• Make day-to-day decisions affecting team members, directly impacting daily operations and team efficiency
• Ensure all associates adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
• Other adhoc duties as assigned

Requirements

• Degree in Engineering or scientific field
• Min 5 years of relevant work experience in validation activities in pharmaceutical field or related highly regulated environment
• Strong understanding and hands on experience supporting, executing, or overseeing manufacturing activities involving aseptic operations, sterilization processes
• Able to provide after office hours support for validation related activities when required

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