Quality Assurance Manager

Created by: Amgen
Added: 14.11.2019
Website: www.amgen.com

Advert description

Key Responsibilities
  • Serve as the main Quality point of contact related to Amgen product at External site
  • Manage External site to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements
  • Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
  • Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
  • Provide quality oversight of the manufacturing, testing, and release of Amgen products at External site
  • Author and drive actionable site inspection readiness plans
  • Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site
  • Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required
  • Identify and mitigate risk at the External site
  • Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
  • Escalate risks or roadblocks to management
  • Drive timely decision making using DAI principles
  • Drive continuous improvements and Amgen first mindset
  • Perform tactical batch disposition activities in support of lot release

Authority
  • Decision to release or reject batches
  • Decision to approve or reject an External site change implementation / deviation
  • Advise on External site status
  • Advise on External site Inspection readiness
  • Identify opportunities and issues, then determine when escalation is necessary

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Master's, Other
Level of Experience 2-5 years

Location

Singapore, Asia
Singapore