Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- 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 changes are managed appropriately to meet the expectation of the global change control board (if applicable) 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 with your team, which may include presentations and facility, utility, equipment documentation review
- Comply with Safety, Health & Environmental (SHE) requirements, mindful of safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
- Observe all site security measures at all times, and report any suspicious characters/objects &
damaged security mechanisms to Site Security immediately
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Job Requirements:
- Bachelor’s Degree in Biomedical Engineering, Biotechnology, Science or equivalent
- Familiar with Change Control Management Systems and stakeholders to involve
- Adherence to safety protocols and regulatory compliance
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
- Excellent communication skills, both written and verbal, in English
