We're looking for a candidate to fill this position in an exciting company.
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.
- 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)