Regulatory Compliance Officer

2 giorni fa


Latina, Lazio, Italia JR Italy A tempo pieno

We are a leading CDMO for anticancer drugs, driven by innovation and investment in new technologies and production methods.

About the Job

This Quality System Specialist position ensures compliance with current regulations and international standards.

Key Responsibilities
  1. Qualify and assess suppliers according to established plans.
  2. Manage quality events and notifications related to suppliers and third-party services.
  3. Develop and maintain the Contamination Control Strategy Document and related metrics.
Audit and Compliance Area
  1. Support internal audits and customer requirements.
  2. Assist in preparing regulatory inspections.
Quality Risk Management
  1. Implement and maintain risk assessment records.
Product Quality Review
  1. Analyze product trends for management review.
Requirements
  1. Master's degree in relevant sciences.
  2. English language proficiency.
  3. GMP knowledge.
  4. Analytical and client-oriented skills.

We believe in an inclusive work environment that fosters collaboration and innovation.



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