Global PV QA & Compliance Partner

Biopharma Careers; Parma; Ibrido; EUR 41.000 - 51.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Descrizione del lavoro

Chiesi Research & Development is recruiting for a Pharmacovigilance QA specialist to ensure the PV quality system complies with regulatory standards across the organization. You will manage deviations, CAPAs, and assist in inspections, with close collaboration to the QPPV and cross-functional teams.

The role requires a Life Sciences degree and 3–5 years in pharmacovigilance/QA, strong knowledge of PV regulations, and fluency in English.

Competenze

• PV QMS (deviations, CAPA, change control) knowledge and experience.
• SOP/WI writing and review, PV tools/databases familiarity.
• Strong knowledge of GVP/PV regulations (EMA/FDA).
• Understanding of PSMF and PV systems; quality systems exposure.

Mansioni

• Ensure PV quality system compliance with regulatory requirements and company standards.
• Manage PV deviations identified through compliance monitoring.
• Monitor CAPAs resulting from audits and deviations.
• Inform the QPPV about non-conformities.
• Review PV SOPs/WIs for regulatory alignment.
• Draft PV SOPs/WIs for QA activities.
• Support inspections/audits by authorities and partners.
• Collaborate on PV data collection and KPI metrics.

Conoscenze

PV QMS knowledge

CAPA process

SOP/WI writing

GVP/PV regulations knowledge

QPPV interface communication

Stakeholder communication

English fluent

Formazione

Degree in Life Sciences (Pharmacy, Biology, Medicine, Biotechnology, Chemistry or equivalent)

Descrizione del lavoro

Chiesi Research & Development is recruiting for a Pharmacovigilance QA specialist to ensure the PV quality system complies with regulatory standards across the organization. You will manage deviations, CAPAs, and assist in inspections, with close collaboration to the QPPV and cross-functional teams.

The role requires a Life Sciences degree and 3–5 years in pharmacovigilance/QA, strong knowledge of PV regulations, and fluency in English.