QA Training & Documentation Specialist (Pharmaceuticals)

TL;DR

QA Training & Documentation Specialist (Pharmaceuticals): Managing training and documentation across the Global TechOps & Supply area with an accent on GMP compliance and regulatory alignment. Focus on implementing a new document management system, overseeing EDMS/LMS governance, and ensuring adherence to EU and FDA guidelines.

Location: Parma, Italy. Relocation support is provided.

Salary: Minimum € 36,000

Company

International research-focused biopharmaceutical group dedicated to sustainable innovation and promoting a healthier world through innovative drug development.

What you will do

• Manage the Electronic Documentation Management System (EDMS) to ensure regulatory alignment and updates.
• Oversee training and documentation governance for the entire Global TechOps & Supply area.
• Coordinate and implement a new document management system at the site.
• Perform quality checks on documents and manage their distribution to suppliers.
• Provide user training, support, and monitor document expiration cycles.
• Support corporate quality audits and inspections by regulatory authorities.

Requirements

• Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, or Engineering).
• At least 5 years of experience in pharmaceutical manufacturing, specifically in Quality Assurance.
• Expert knowledge of EU and FDA regulations and specialized expertise in GMP compliance.
• Fluent English (both written and spoken).
• Proven ability to manage multiple projects and analyze technical risks to find shared solutions.

Culture & Benefits

• Comprehensive healthcare programs and private medical insurance.
• Pension, wellbeing, and flexible benefits programs.
• Flexible working arrangements and remote work options.
• Robust relocation support and tax assistance for foreign colleagues.
• Competitive salary package including performance bonuses.