QA Specialist Trainee

2 days ago

Tuas Bay, Singapore Roche Services & Solutions Operations APAC Full time $40,000 - $80,000 per year

1)    Purpose

  • Responsible for the maintenance and continuous improvement of the Change Control systems and processes.
  • Ensure GMP compliance with the change control process.

2)    Key Responsibilities

Technical and Functional:

  • 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

Safety, Health & Environment:

  • 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.

Lean Production System:

  • 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.

3)  Key Interfaces:

  • Manufacturing, Local MSAT, Engineering
  • Quality Functions (e.g. QA Ops, QC)
  • Global Change Management BPOs and BPMs
  • PT Regulatory

4)   Qualifications

  • 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

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