Quality Officer - Singapore - GMP Group

GMP Group

Verified Company

Singapore

2 weeks ago

Posted by:

Wei Jie

beBee Recruiter

Description

Jobscope:

Review documents / analytical test results and assess all attributes/elements contributing to product release to determine if product / equipment is fit for release.
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 Periodic Product Review (PPR) activities and compile the report.
Lead or participate in investigations arising from customer complaints, returned goods or product failure etc, and accurately assess the impact of the complaint/failure/investigation so as to make appropriate recommendations on remedial actions for followup.
Participate as an audit team member in the preparation of site audits by corporate and external groups such as the Food and Drug Administration (US), Health Sciences Authority (HSA)
Draft, compile, review and update appropriate procedures and listing relating to GMP and operational quality.
Update Technical Terms of Supply/Quality Agreement and issue Technical Terms of Supply/Quality Agreement change control to customer as needs arise.
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 etc. for the manufacture and testing of the products.
Conduct regular walk downs to production facilities including supporting areas. These areas include but not exclusive to production building, laboratories, engineering building and storage facilities

Requirements: