Head Audit - Corporate Quality
Centrient Pharmaceuticals Netherlands
Gurugram, Haryana, Indien
1d ago
source : JobLeads

Quality Gurugram, Haryana, India Full time

The Head of Audit assures that the Quality related Audit process throughout Centrient sites is effective and efficient as a means to monitor, control and improve the quality compliance at all Centrient sites and also provides direction, support and advice with senior accountability on external audits to Centrient sites and CMO’s, from the audit planning to the close-out of CAPA plans.

He ensures an effective Inspection readiness status.

Key Individual Accountabilities

  • Ensure the efficacy of corporate audits (level 2), Customer audits (level 3) and Regulatory audits (level 4) to Centrient sites and CMO’s, leading to corrective actions and resolution of non-compliance issues.
  • Support customer (level 3) and Regulatory (level 4) audits to Centrient sites.
  • Take the lead on the Corporate Audit Plan and ensure the efficacy of Corporate audits to global suppliers.
  • Create and maintain an effective and compliant Pool of auditors.
  • Leadership, Training and support to Centrient employees acting as Quality Auditors.
  • Leadership role for effective implementation of Corporate Audits Plan.
  • Ensures Inspection readiness at manufacturing sites and CMOs.
  • Provides Inspection Intelligence to Centrient.
  • Key Shared Accountabilities

  • Support the Centrient Excom and Leadership Teams in Regulatory Inspections as appropriate and ensure that Centrient interests are safeguarded and assure Centrient’s GMP LTO.
  • Support Centrient Sites during customer audits and health authority regulatory inspections.
  • Support the PSCI audits process, either Centrient being the Auditee, the Auditor or the Sponsor.
  • Requirements

  • Post Graduate
  • Around15 years of experience in Pharmaceutical industry.
  • Around 5 years of experience in Global or Corporate Quality role.
  • Quality and FDA Compliance mindset.
  • Technical & Scientific know how.
  • Communication and Interpersonal Skills.
  • Ability to planning and organizing.
  • Ability to connect with and to obtain the commitment from all functions within Centrient.
  • Dealing with cultural differences (e.g. colleagues, authorities, and customers)
  • Pool of Centrient Auditors
  • Audits Lifecyle
  • Corporate audits Plan to Global suppliers
  • Candidates applying for the location should have relevant applicable documents and work permits. In absence of this, the application will not be considered.

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