Supply Chain Quality Assurance Specialist
3 giorni fa
We are seeking a highly skilled Supply Chain Quality Assurance Specialist to join our team at Randstad Italia Spa in Rome. The ideal candidate will have a strong background in quality assurance and a deep understanding of GMP regulations.
Key Responsibilities- Provide quality assurance management of key contractors for Pfizer, ensuring compliance with c-GMPs and registration file requirements.
- Develop and maintain relationships with contract manufacturers, negotiating and communicating quality requirements.
- Initiate, review, and approve regulatory changes through the Pfizer enterprise system (PDM).
- Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) department or Local Regulatory Affairs for regulatory activities involving ESOQ contractors.
- Bachelor's degree in Science, Engineering, or related technical discipline with at least 7 years of experience in a GXP setting and/or Regulatory Affairs role.
- At least 4 years of Product Quality Assurance experience in a GMP environment, preferably with aseptic manufacturing experience.
- Advanced computer skills, including MS Office and enterprise systems such as SAP, QTS, PDM, and Documentum platforms.
- Excellent verbal and written communication skills, including presentation skills.
€60,000 - €80,000 per year, depending on experience.
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