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Quality Technician Oversight Specialist

2 weeks ago

Singapore beBeeQuality Full time $90,000 - $120,000

Role Summary:

  • To provide quality oversight for manufacturing operations and ensure full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements.

Key Responsibilities:

  1. Assess, review and approve all cGMP related documentation.
  2. Review batch and quality documentations to assess whether the product is fit for purpose prior to making usage decision.
  3. Assess, review and approve changes that may have an impact on product quality, validation and/or cGMP compliance to ensure timely product release to customers.
  4. Inspect and release process equipment/plant after turnaround.
  5. Co-ordinate, review and approve Periodic Reviews of products, systems and processes.
  6. Conduct and support site audit inspection preparation and participate as an audit team member in audits, including internal and external audits.
  7. Draft, review, update and be subject matter expert for appropriate procedures and listing relating to cGMP, site supplier management, and operational quality and ensure they are in full compliance with cGMP and company requirements.
  8. Support shift operations which include production, engineering, laboratory etc. to provide the necessary quality oversight in terms of activities such as change control, deviation investigation e.g. initial impact and remedial action assessment.
  9. Provide quality oversight of shift operations, laboratory and engineering team in all aspects of GMP, including regular walk downs to production facilities and supporting areas with the necessary coaching of the shift staff.

Requirements:

  • Professional diploma in chemical engineering.
  • Min 3 years of experience in manufacturing industry.
  • Experience in quality and manufacturing processes.
  • Experience in pharmaceutical industry or healthcare sector.
  • Open to candidates who are keen in rotating 12 hour - shift.

Technical Requirements:

  • Basic knowledge of GMP.
  • Basic knowledge of quality and manufacturing processes.
  • Good knowledge of corporate management systems.
  • Good audit skills.
  • Knowledge of equipment operations.

Business Requirements:

  • Good interpersonal skills.
  • Good oral and written communication skills.
  • Good investigating skills.
  • Good project management skills.

Seniority level: Not Applicable.

Employment type: Full-time.

Job function: Quality Assurance.

Industries: Pharmaceutical Manufacturing.