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• Job Title: QC Analyst
• Location: Scoppito

About the job

The QC Analyst is responsible for performing analytical testing on raw materials, in-process samples, and finished pharmaceutical products to ensure compliance with established specifications, regulatory requirements, and quality standards. The role supports the release of products and maintains the highest standards of quality and safety.

Main Responsibilities:

Testing & Analysis:

• Perform physical, chemical, and microbiological testing on raw materials, intermediates, and finished products according to approved methods and SOPs
• Operate and maintain laboratory instruments (HPLC, GC, UV-Vis, dissolution apparatus, etc.)
• Execute stability studies and analyze stability samples according to protocols
• Conduct method validation and verification activities as required

Documentation & Compliance:

• Accurately document all testing activities, results, and observations in laboratory notebooks and electronic systems (LIMS)
• Ensure compliance with GMP, GDP, and regulatory requirements (FDA, EMA, ICH guidelines)
• Review and approve analytical data, ensuring accuracy and completeness
• Participate in internal and external audits and inspections

Quality & Continuous Improvement:

• Investigate out-of-specification (OOS) and out-of-trend (OOT) results
• Participate in deviation investigations, CAPA, and change control processes
• Contribute to continuous improvement initiatives and laboratory efficiency projects
• Maintain laboratory equipment through calibration, qualification, and preventive maintenance

Collaboration & Communication:

• Collaborate with Production, Quality Assurance, R&D, and Regulatory Affairs teams
• Communicate testing results and quality issues to relevant stakeholders
• Support training of new team members and laboratory personnel

About You:

Experience:

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, or related scientific field
• Master's degree preferred
• Minimum 2-3 years of experience in a pharmaceutical QC laboratory
• Experience with analytical techniques (HPLC, GC, titration, dissolution, etc.)
• Knowledge of GMP regulations and pharmaceutical quality systems

Soft and Technical Skills:

• Proficiency in analytical instrumentation and laboratory techniques
• Experience with LIMS and electronic documentation systems
• Understanding of pharmacopeial methods (USP, EP, JP)
• Knowledge of statistical analysis and data interpretation
• Strong attention to detail and accuracy
• Excellent problem-solving and analytical thinking
• Effective communication skills (written and verbal)
• Ability to work independently and as part of a team
• Time management and organizational skills

Languages: Fluent with Italian and English

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