QA GMP Senior Auditor
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* annual bonus
* pension
* private medical insurance
* wellbeing programme
* flexible benefits programme
* relocation support Responsabilità
* Plan and execute second party audits of GMP suppliers and GMP service providers (CMOs, contract laboratories)
* Execute first party audits
* Monitor corrective and preventive actions and ensure timely closure
* Coordinate external consultants supporting Auditing & Supplier Qualification
- GMP & Medical Device Unit
* Define, review and finalise Quality Agreements with GMP suppliers and service providers
* Support hosting of GMP inspections
* Collect and review data for Management Review and KPIs/metrics
* Finalize and standardise SOPs related to auditing and supplier qualification processes
* Organise and support training on GMP requirements and related procedures
* Act as QA reference for audit and qualification activities involving sterile, biological and biotech products
* Interact with CMC, Regulatory Affairs, Clinical Supply, Procurement and cross-functional teams to qualify providers Requisiti fondamentali
* Scientific degree, preferably in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related discipline
* At least three years of experience as auditor in pharmaceutical companies
* Experience in Quality Assurance, supplier qualification or audit activities within pharmaceutical development or manufacturing
* Knowledge of GMP requirements
* Knowledge of auditing techniques
* Knowledge of sterility assurance principles and GMP expectations for sterile and biotech products
* Leadership
* Organisational skills
* Stress management
* Knowledge of GMP requirements
* Auditing techniques
* Sterility assurance principles
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