Pilot Plant Quality Control Associate Expert

Healthcare Businesswomen’s Association; Ivrea; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical organization is seeking a qualified individual for a laboratory role in Ivrea, Italy. The successful candidate will perform analyses on various materials, ensuring compliance with GMP and data integrity principles. Essential qualifications include a degree in Chemistry, lab experience in the pharmaceutical industry, and fluency in both Italian and English. This is an on-site position that requires strong laboratory skills and attention to detail.

Competenze

• Solid technical-scientific knowledge of pharmaceutical/chemical QC or equivalent analysis.
• Previous experience working in a laboratory environment in the pharmaceutical industry.
• Fluent in Italian and English.

Mansioni

• Executes analyses on excipients, raw materials, finished products, and packaging.
• Conducts stability studies and method validations.
• Records analytical data and reviews GMP documentation.
• Collaborates with QA, Production, and R&D on method transfers.

Conoscenze

Laboratory analysis

GMP compliance

Data integrity

Chemistry knowledge

Formazione

Degree in Chemistry

Descrizione del lavoro

Job Description Summary

Location: Ivrea, Italy #onsite

Role Purpose:

This role utilizes chemistry laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods & current Compendia.

Job Description

Key Responsibilities

• Executes analyses on excipients, raw materials, finished products, and packaging per internal SOPs and applicable pharmacopeias.
• Conducts stability studies, process and method validations, and activities related to tech transfer of pharmaceutical products.
• Performs instrument qualification and re-qualification (IQ/OQ/PQ) according to internal procedures.
• Records analytical data in compliance with ALCOA+ principles and data integrity requirements.
• Reviews GMP documentation, batch records, analytical reports, and certificates for completeness and compliance.
• Collaborates with QA, Production, and R&D; supports method transfers, troubleshooting, and safe lab/5S practices.
• Participates in audits and inspections by providing data and responses; contributes to CAPA, deviations, change control, and SOP updates.
• Tracks KPIs: on-time completion and right-first-time rates, data integrity compliance, audit outcomes, documentation quality, and continuous improvement impact.

Essential Requirements

• Degree in Chemistry
• Solid technical-scientific knowledge of pharmaceutical/chemical QC or equivalent analysis
• Previous experience working in a laboratory environment in the pharmaceutical industry
• Experience in GMP environment
• Fluent in Italian and English

Skills Desired

No specific list provided.