Sr Associate, Quality Assurance

Responsibilities

The new employee, reporting directly to the Quality Operation Coordinator, will be part of a team of 9 people.

As a Quality Operation Specialist, he/she will play a crucial role in conducting investigations related to deviations, complaints, and other quality events. Working closely with Quality Assurance and other internal and external stakeholders, he/she will be responsible for overseeing production activities, verifying on the shop floor the accurate completion of Batch Record Reviews, logbooks, and other GMP documentation, identifying root causes, ensuring the implementation of corrective and preventive actions, and supporting regulatory compliance.

Additionally, the Quality Operation Specialist will:

• Lead and coordinate investigations for deviations, complaints, and quality events, ensuring robust root cause identification, risk assessment, and implementation of effective corrective and preventive actions (CAPAs).
• Manage market and customer complaints, including product impact assessments, recurrence analysis, and coordination of investigations with internal and external stakeholders.
• Facilitate cross-functional investigation teams and ensure the timely closure of deviations, complaints, and CAPAs in accordance with internal procedures and GMP requirements.
• Monitor investigation and CAPA performance metrics and escalate quality risks when necessary.
• Draft detailed investigation reports by assessing product impact, identifying root causes, and defining corrective and preventive actions, while verifying their execution and effectiveness.
• Oversee 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.
• Contribute to periodic quality reviews through the analysis of deviations, complaints, CAPA effectiveness, and quality trends.
• Author, review, and update GMP documentation, including SOPs and Master Batch Records.
• Maintain quality records within the electronic Quality Management System (TrackWise), ensuring data accuracy, compliance, and the timely closure of assigned quality events.

Specific Skills, Educational Requirements and Experience

• Bachelor's degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, or a related scientific field.
• Minimum of 3 to 4 years of experience within a pharmaceutical manufacturing environment.
• Knowledge of investigation and root cause analysis tools, such as Fishbone Diagram, 5 Whys, and FMEA, is preferred.
• Strong command of both English and Italian; excellent technical writing skills are essential.
• Familiarity with liquid and solid oral dosage manufacturing processes would be considered an advantage.
• Strong analytical, communication, and cross-functional collaboration skills.
• Demonstrated problem-solving abilities and strong attention to detail.
• Ability to manage multiple priorities and meet deadlines in a dynamic environment.

Pay range 40.000€ - 46.000€ 

The compensation range indicated in this job posting represents an estimated average range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements