Sr Associate, Quality Assurance

Alfasigma; Pomezia; In loco; EUR 40.000 - 46.000; Tempo pieno

Descrizione del lavoro

Alfasigma in Italy seeks a Quality Operation Specialist reporting to the Quality Operation Coordinator, within a team of 9. You will lead investigations for deviations, complaints and quality events, supervise batch records, logbooks and GMP documents on the shop floor, and help implement CAPAs.

You will coordinate cross-functional teams, support audits and regulatory inspections, monitor CAPA metrics, draft investigation reports, and ensure SOP/GMP compliance while maintaining TrackWise records.

Competenze

• Bachelor’s degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, or related field.
• Knowledge of investigation and root cause analysis tools (Fishbone Diagram, 5 Whys, FMEA).
• Strong command of English and Italian; excellent technical writing skills.
• Experience in pharmaceutical manufacturing preferred (3–4 years).
• Familiarity with GMP, SOPs and CAPA processes is advantageous.

Mansioni

• Lead and coordinate investigations for deviations, complaints and quality events with robust root cause analysis and CAPA actions.
• Manage market and customer complaints including impact assessments and recurrence analysis with stakeholders.
• Facilitate cross-functional teams and ensure timely closure of investigations and CAPAs per GMP procedures.
• Monitor metrics, escalate risks, and draft detailed investigation reports with corrective actions and effectiveness checks.
• Oversee production activities to ensure SOP and GMP compliance and support audits/regulatory inspections.
• Contribute to periodic quality reviews and maintain GMP documentation (SOPs, Master Batch Records) in TrackWise.

Conoscenze

Root cause analysis

Investigations

CAPA management

Technical writing

Cross-functional collaboration

English/Italian bilingual

Formazione

Bachelor's degree in Pharmaceutical Chemistry and Technology or related field

Strumenti

TrackWise

Descrizione del lavoro

Job description

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 escal​ate 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.

Job description

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 escal​ate 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