Quality System & Compliance Manager at Corden Pharma - A Full-Service CDMO
CordenPharma is a leading pharmaceutical development and production CDMO based in Italy with over 2,600 employees worldwide. The company specializes in active pharmaceutical ingredients (API), excipients, finished pharmaceutical products (DP), and offers flexible and specialized solutions on five technology platforms: Peptides, Lipids, Carbohydrates, Injectable, High Potent and Oncological, and Small Molecules. The Caponago plant focuses on sterile injectable dosage forms and supports the entire product life cycle from aseptic filling to final sterility and labeling.
Responsibilities
* Guarantee correct management of deviations and quality events, including definition of preventive and corrective actions and monitoring closure within expected times.
* Interface with customers for deviation and event management in accordance with applicable quality agreements.
* Review of plant processes and documentation with GMP impact, identifying potential non‑compliance risks.
* Identify action plans to reduce identified risks and manage monitoring.
* Ensure compliance with Data Integrity principles through continuous improvement plans.
* Collaborate with involved functions to prepare risk assessments and define mitigation actions.
* Execute activities related to regulatory and client inspections, maintaining inspection‑ready status.
* Monitor site KPI performance and define improvement actions.
* Plan GMP training for site personnel and define training plan for the function.
Qualifications
* Bachelor’s degree in scientific subjects.
* Excellent English language knowledge.
* Knowledge of GMP with focus on aseptic pharmaceutical production.
* Proficiency with statistical tools for data analysis.
* Deep understanding of root cause analysis techniques.
* Preference for experience with Trackwise and SAP systems.
Soft skills: strong communication, managerial and relational abilities at all company levels, negotiation skills, stress management, flexibility.
Internal canteen. Portable laptop. If you enjoy teamwork and dynamic growth, you are in the right place!
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