Company
INITS is a dynamic consulting firm driven by quality and innovation, dedicated to supporting biotechnology companies in delivering life-changing medicines to patients.

Specializing in pharmaceutical development, INITS provides expertise in CMC (Chemistry, Manufacturing, and Controls), IMP (Investigational Medicinal Products), regulatory affairs, quality assurance, and audits.

To support its growing business, INITS is recruiting a CMC Quality Assurance Consultant (M/F/X).

Responsibilities
As a CMC Quality Assurance Consultant at INITS, you will play a key role in supporting our clients throughout the development phases of their pharmaceutical products. Your main responsibilities will include:

• Consulting and Guidance: Provide technical and strategic advice in project management and compliance with Good Manufacturing Practices (GMP). Ensure the implementation of clients’ quality systems, plan and conduct audits, and deliver training.

• Quality Management Systems: Support teams in implementing quality processes for documentation management, training, audits, quality events, subcontractors, batch recalls, and risk management. Draft procedures, instructions, forms, and dashboards. Oversee quality activities in collaboration with internal teams, ensuring deadlines, objectives, and quality requirements are met. Prepare and lead quality meetings.

• Training: Train client personnel on quality documentation and Good Manufacturing Practices (GMP), including topics like Data Integrity and process compliance.

• Operational Quality Assurance: Review operational documents, including batch records (blank and executed), quality agreements, and quality events.

• Audits: Conduct audits of manufacturing, analytical, storage, and QP sites involved in clients’ GMP activities.

You will be a trusted partner for our clients, actively contributing to the success of their projects and the quality of the products delivered to the market.

Profile

• A scientific degree with a specialization in pharmaceutical Quality Assurance.

• At least 5 years of experience in pharmaceutical development, including biologics and/or finished product manufacturing processes.

• Certified auditor with a strong command of Good Manufacturing Practices (GMP) and pharmaceutical industry standards.

• Skilled in navigating agile environments with strong project management capabilities.

• Proficiency in Microsoft Office and fluency in English.

• Organized, rigorous, and an excellent communicator with the ability to work both independently and as part of a team.

Employment Conditions

• Competitive salary based on experience.

• Benefits: Performance-based bonus, 80% coverage of health insurance, employee savings plan (PEE), and more.

• Location: Montpellier, with remote work options available.

Join the INITS adventure today!