QA Specialist Trainee

Description

• Ensure adherence to the Change Control management systems and processes
• Develop competency and proficiency in the QA Change Control process and the associated tools, supporting the delivery of training for change users as needed
• Evaluate Change Control requests for process, validation, regulatory and product impact
• Coordinate the review and approval process of change requests to ensure timely execution of changes
• Ensure all site major changes are managed appropriately to meet the expectation of the global change control board and meets site project timelines
• Participate in cross functional and cross site change management forums
• Collaborate with departments to ensure change control activities are executed efficiently and effectively, to provide supporting assistance to stakeholders in the process
• Ensure completion of required change control actions prior to lifting lot disposition restrictions
• Assist in the development and delivery of training materials and qualifications for Change Control processes and Change Management applications
• Perform Change Records review in support of Annual Product Review activities
• Ensure maintenance and continuous improvement of change control and processes
• Support regulatory inspections and provide audit support, which may include facility, utility, equipment documentation review

Qualifications

Highest qualification: University

• Diploma/Degree in Engineering or Science discipline is preferred
• Experience (may vary depending on site size/scope):

• Fresh graduates/mid-career professionals who are switching out of other industries
• Knowledge/Skills/Competencies
• Strong knowledge in of Change Control principles, practices and standards for the pharmaceutical industry
• Strong knowledge of cGMP regulations relevant to the pharmaceutical industry
• Systematic, meticulous and analytical approach to evaluation and execution of tasks
• Demonstrate excellent verbal and written communication skills in English