Pomezia, IT
QA Operations Specialist
Are you passionate about quality and compliance in the pharmaceutical world? We’re looking for a Quality Assurance Operations Specialist to play a vital role in ensuring our products meet the highest regulatory standards and patient safety expectations.
If you have a keen eye for detail, a proactive mindset, and a drive to make an impact in a fast-paced, mission-driven environment — we want to hear from you!
The position:
The new employee, reporting directly to the Quality Operation Coordinator, will be part of a team of 7 people. As a Quality Operation Specialist, will play a crucial role in executing investigations for both deviations and complaints. Working alongside Quality Assurance and other internal and external stakeholders, he/she will be responsible for overseeing production, verifying on the floor the proper completion of Batch Record Reviews, log-books, and other GMP documents, and for identifying root causes, ensuring corrective and preventive actions are in place, and supporting regulatory compliance.
Additionally the Quality Operations Specialist will:
- Lead investigations for deviations and quality events, working closely with Quality Assurance, SMEs, and other functions to assess interventions and ensure compliance with GMP guidelines and Alfasigma policies.
- Draft detailed investigation reports by assessing product impact, identifying root causes and implementing corrective actions, and preventive measures, while verifying the execution and effectiveness of those actions.
- Serve as the internal point of contact for critical investigations, supporting the use of investigative methods and ensuring that root causes of deviations are properly addressed.
- Collaborate with cross-functional teams to drive process improvements, resolve investigations, and maintain compliance.
- Oversight production activities to ensure compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
- Support audits and regulatory inspections, ensuring compliance with industry standards and driving continuous process improvement.
- Data analysis using statistical tool and KPI management.
- Author and update GMP documentation, including SOPs and Master Batch records.
Specific Skills, Educational Requirements and Experience:
- Bachelor’s degree in CTF, Pharmacy, Chemistry, or a related scientific field.
- At least 3-4 years working within pharmaceutical manufacturing.
- Knowledge of main investigation tools (Fishbone, 5 Whys, FMEA) is preferred.
- Strong command of the English & Italian languages, technical writing skills are a must.
- Familiarity with pharmaceutical production processes would be considered a plus.
- Strong communication and teamwork abilities.
- Problem-solving skills and attention to detail.
- Skilled in managing projects and meeting deadlines.
Company:
Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.