Quality Assurance Operations Specialist

Alfasigma; Pomezia; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical company in Italy is seeking a Quality Assurance Operations Specialist to ensure compliance with regulatory standards. The role involves leading investigations for deviations, drafting reports, and overseeing production activities. Candidates should have a relevant degree and 3-4 years of experience in the field, with strong analytical and communication skills. This is a full-time position based in Pomezia, Italy.

Competenze

• At least 3-4 years of experience in pharmaceutical manufacturing.
• Strong command of English and Italian, with technical writing skills.
• Familiarity with pharmaceutical production processes.

Mansioni

• Lead investigations for deviations and quality events.
• Draft detailed investigation reports assessing product impact.
• Oversee production activities to ensure compliance with SOPs and GMP.

Conoscenze

Attention to detail

Problem-solving skills

Communication skills

Teamwork abilities

Project management skills

Formazione

Bachelor’s degree in CTF, Pharmacy, Chemistry, or related scientific field

Strumenti

Fishbone analysis

5 Whys

FMEA

Descrizione del lavoro

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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, they will play a crucial role in executing investigations for deviations and complaints. Working alongside Quality Assurance and other stakeholders, they will oversee production, verify proper completion of Batch Record Reviews, log-books, and other GMP documents, identify root causes, ensure corrective and preventive actions are in place, and support regulatory compliance.

Additionally, the Quality Operation Specialist will :

• Lead investigations for deviations and quality events, working closely with Quality Assurance, SMEs, and other functions to ensure compliance with GMP guidelines and Alfasigma policies.
• Draft detailed investigation reports assessing product impact, identifying root causes, and implementing corrective and preventive actions, verifying their effectiveness.
• Serve as the internal point of contact for critical investigations, supporting investigative methods and ensuring root causes are addressed.
• Collaborate with cross-functional teams to drive process improvements, resolve investigations, and maintain compliance.
• Oversee production activities to ensure compliance with SOPs and GMP.
• Support audits and regulatory inspections, ensuring compliance and continuous process improvement.
• Perform data analysis using statistical tools and manage KPIs.
• 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 related scientific field.
• At least 3-4 years of experience in pharmaceutical manufacturing.
• Knowledge of investigation tools (Fishbone, 5 Whys, FMEA) is preferred.
• Strong command of English and Italian, with technical writing skills.
• Familiarity with pharmaceutical production processes is a plus.
• Strong communication and teamwork abilities.
• Problem-solving skills and attention to detail.
• Project management skills and ability to meet deadlines.

Company :

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, with headquarters in Bologna and Milan. It operates in over 100 markets worldwide, with offices, production sites, and R&D labs across Italy, the US, Spain, Germany, Mexico, and China. Employing approximately 4,000 people, Alfasigma focuses on research, development, production, and distribution of medicinal products in areas like Gastroenterology, Vascular, and Rheumatology.

**Note:** This job posting is active and accepting applications.