QA Assistant

Location: Borgo San Michele

RoleQA Assistant Location Borgo  San Michele – Latina, Italy Purpose For  our manufacturing site in Borgo San Michele (Latina), we’re looking for a permanent hire to join the Quality team. The role focuses on ensuring that products comply with national and international pharmaceutical regulations in terms of quality control and documentation. You’ll be part of the Quality Assurance team, helping to meet GMP and internal quality standards.

Responsibilities Perform all controls required by procedures for second-level approval of Batch Records.

Act as Quality Leader/Quality Approver in the management of investigations, ensuring appropriate review and approval of records.

Ensure investigations are complete, that compliance and quality impact are properly assessed, and that appropriate corrections and corrective actions are defined and implemented.

Investigate complex quality issues (non-conformances) and ensure appropriate communication within and outside the site; act as Escalation Lead in accordance with the relevant procedure.

Ensure that non-standard shipments and shipments under Quarantine are managed in compliance with procedures.

Support the different site departments in resolving issues with potential quality impact and actively contribute to the definition of improvement actions.

Participate in cross‑functional meetings to define site business priorities and organize team activities in line with defined capacity, ensuring execution of both standard and fast‑track activities.

Contribute to the effectiveness and efficiency of the Quality System by monitoring departmental KPIs and implementing appropriate improvement actions where necessary.

Actively participate in the department’s preparation for regulatory and customer inspections and act as Subject Matter Expert (SME) during inspection execution.

Qualifications Master’s degree or diploma in a scientific field, or an equivalent combination of education and experience in the pharmaceutical industry.

At least 2years of experience in a quality field in a pharmaceutical company, and experience as an investigator.

Excellent English language skills.

Good knowledge of Microsoft Office suite.

Key Skills Administrative Support Communication Compliance  Management Controls Compliance Execution FocusISO
9001

Persistence and Tenacity Problem Solving Quality Control (QC)
Quality Control Testing Quality Standards Quality Systems Documentation Quality Validation Report Writing Standard Operating Procedure (SOP)
Teamwork Technologically Savvy Compensation Base  salary range: €33,700.00–€54,395.00. Additional annual bonus with a target (% of pay) based on pay grade/location and company performance. Possible sales commissions.

Benefits Vacation days Parental leave (minimum 12weeks)
Bereavement leave

Caregiver leave

Volunteer leave

Well‑being reimbursement

Programs for financial, physical and mental health

Service anniversary and recognition awards

Participation in insurance plans (subject to plan terms)
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