Operational Quality Assurance Specialist

1 week ago

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

Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the quality and compliance of our products.

Job Description
  • Provide quality oversight for manufacturing operations to ensure full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements.
  • Assess, review and approve all cGMP related documentation.
  • Review batch and quality documentations to assess whether the product is fit for purpose prior to making usage decisions.
  • 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.
  • Inspect and release process equipment/plant after turnaround.
  • Coordinate, review and approve Periodic Reviews of products, systems and processes.
  • Conduct and support site audit inspection preparation and participate as an audit team member in audits, including internal and external audits.
  • 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 GSK requirements.
  • 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 eg. Initial impact and remedial action assessment.
  • Provide quality oversight of shift operations, laboratory and engineering team in all aspects of GMP, not limiting to regular walk downs to production facilities including supporting areas with the necessary coaching of the shift staff.
Required Skills and Qualifications
  • Professional Diploma in chemical engineering or bioengineering.
  • Min 1 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.
Benefits

The successful candidate will enjoy a competitive salary and benefits package, including opportunities for career growth and development.

As a member of our team, you will have the opportunity to work with a dynamic and collaborative group of professionals who share your passion for quality and excellence.

We offer a range of training and development programs to help you achieve your goals and advance your career.

Our company culture emphasizes teamwork, innovation and customer satisfaction, providing a positive and rewarding work environment.

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