R&D Audit

1 week ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 5,00,000 - ₹ 15,00,000 per year

What you will do

In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does.

  • Data entry into Amgens Quality System of approved audit responses
  • Audit resourcing/planning
  • Quarterly Investigator Site audit planning including identifying audit resourc es t hrough risk assessment of audit targets on a regular basi s
  • Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits
  • Updating Audi t tracking and accountability t ools and distrib uting/communicatin g all ocations to the audit teams
  • Compiling Audit reporting metrics and communication

  • Manage Audit documentation and filing

  • Supporting outsourced audits by:

  • Supporting outsourced audit resourcing/planning for Audits
  • Provide necessary tools, reports/documentation, and access to systems for outsourced Audits
  • Review initial draft audit reports, audit responses and debrief slides.
  • Schedule and facilitate Quality Lead (pre-audit meetings) and audit debrief meetings
  • QC Data entry into AMS of audit findings
  • Confirming data entry into RDCS of approved audit responses
  • Oversee timelines met for issuance of Initial audit reports; review of audit responses and issuing Final Audit Reports
  • Provide guidance and resolve queries from external Audit vendors
  • Weekly Meeting with external audit vendor to review tasks and status of audits
  • Communicate noncompliance to Manager
  • Administrative Support (includes maintaining & updating distribution lists and templates)
  • Data entry/QC in to the Audit Management System (Trackwise) of audit findings
  • Administrative support for audit resourcing/planning
  • Manages Audit documentation and filing
  • Ensures that the Audit Archive is updated with Final audit reports and closure memos and Plans/Agendas where applicable
  • Follow up with CAPA Owners for completion dates and objective evidence
  • Review and Append Objective evidence in Amgens Quality System and close record

Basic Qualifications:

  • Masters degree in Life sciences or related field

Preferred Qualifications:

  • Minimum of 3-5 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
  • Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities
  • Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.
  • Quality Assurance Qualification/Certification (preferred)

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