QA Specialist Trainee - Train & Place program
- Singapore
- Permanent
- Full-time
- Responsible for the maintenance and continuous improvement of the Change Control systems and processes.
- Ensure GMP compliance with the change control process.
- 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
- Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
- Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
- Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviours through the use and application of LPS tools for continuous improvement initiatives.
- Manufacturing, Local MSAT, Engineering
- Quality Functions (e.g. QA Ops, QC)
- Global Change Management BPOs and BPMs
- PT Regulatory
- Education:
- 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