Scoppito, ITA
19 hours ago
Quality Control Biochem / Chemistry Testing L1-1
+ **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 **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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