Lavori attuali relativi a Quality System and Improvement Specialist - Monza, Lombardia - Thermo Fisher Scientific
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Quality System Director
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Manufacturing Process Specialist
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Manufacturing Process Specialist
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Manufacturing Process Specialist
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Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoKey Responsibilities:Develop and implement advanced root cause analysis methodologies to solve complex technical problems.Collaborate with cross-functional teams to drive problem-solving and continuous improvement initiatives.Conduct thorough investigations and provide expert recommendations to prevent errors and deviations.Implement and optimize...
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Cassina Customer Quality Specialist
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Quality Specialist
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Cassina Customer Quality Specialist
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Quality Assurance Specialist
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Monza, Lombardia, Italia Gi Group S.p.A A tempo pienoJob Title: Quality Assurance SpecialistGi Group S.p.A. is seeking a highly skilled Quality Assurance Specialist to join our team in Monza, Italy. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our pharmaceutical products and processes.Key Responsibilities:Develop and implement quality control procedures to ensure...
Quality System and Improvement Specialist
2 mesi fa
Job Summary
We are seeking a highly skilled Quality System and Improvement Specialist to join our team at Thermo Fisher Scientific. As a key member of our organization, you will play a critical role in ensuring the compliance of our mRNA site with quality regulations, including laws, GMP, FDA, and ATMP.
Key Responsibilities
- Quality System Management
- Conduct thorough assessments and audits to verify the suitability, reliability, and performance of quality systems used in GMP manufacturing and testing.
- Collaborate with Quality Assurance, QP, QC, and Manufacturing teams to ensure that our mRNA organization meets cGMP and Corporate Standards throughout the product life cycle.
- Regulatory Compliance
- Ensure compliance with regulatory guidelines and industry standards, including Good Manufacturing Practices (GMP) and relevant regulations outlined by the FDA and ICH.
- Maintain detailed records to demonstrate proper management of quality, ensuring traceability, accountability, and transparency.
- Continuous Improvement
- Support the continuous improvement of quality across the mRNA organization.
- Document and assess the impact of planned changes to facilities and processes that support the quality of the product.
Requirements
- Currently pursuing a Bachelor's or Master's degree in a relevant field such as Pharmaceutical Industry or a related area. Equivalent experience will also be considered.
- Strong interest in continuous improvement.
- Pragmatic and focused on easy and simple solutions for the shop floor.
- Knowledge of GMP guidelines and regulations is highly desirable.
- Excellent analytical and problem-solving skills, with the ability to interpret and present data effectively.
- Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
- Self-motivated and capable of working autonomously, while also being proactive in collaborating with others.
- Familiarity with production and quality risk management processes.
- Listening, negotiation, and communication skills.
- Oriented towards prioritization and results achievement.
- Experience in Pharma Operations and Quality Units of a pharmaceutical company (at least 5 years).
- Proficiency in English.
