Operational Quality Assurance Specialist

6 days ago


Singapore GlaxoSmithKline Full time
Job Description:

At GlaxoSmithKline, we are committed to preventing and treating disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas.

As an Operational Quality Assurance Specialist, you will be responsible for ensuring full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements. You will assess, review and approve all cGMP related documentation, and ensure timely product release to customers. Your duties will include inspecting and releasing process equipment/plant after turnaround, co-ordinating, reviewing and approving Periodic Reviews of products, systems and processes, and conducting and supporting site audit inspection preparation and participation as an audit team member in audits.

You will provide quality oversight of shift operations, laboratory and engineering team in all aspects of GMP, including regular walk downs to production facilities and coaching of the shift staff. You will also support shift operations which include production, engineering, laboratory etc., providing necessary quality oversight in terms of activities such as change control, deviation investigation e.g. Initial impact and remedial action assessment.

We are looking for a professional with a Diploma in any science or engineering related fields and minimum 3 years of experience in pharma/healthcare, open to fresh graduates as well. Experience in quality and manufacturing processes, pharmaceutical industry or healthcare sector is preferred.

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