Senior Product Stability Specialist

Get 360Pharma; Beerse; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Get 360Pharma is seeking a Product Quality Specialist to manage stability across late development to full commercial lifecycle for a portfolio of products in Europe. You will act as Stability SME, ensure regulatory alignment, and collaborate with PQI/PQO/PQL and other functions to maintain quality across the CoE.

You will work independently with minimal guidance, mentor junior team members, support stability data in regulatory filings, and drive continuous improvement in stability processes and

Qualifications

• End-to-end accountability for stability management across product lifecycle.
• Expertise in stability with ability to interpret regulatory requirements.
• Support PQI/PQO/PQL and contribute to Stability CoE objectives.
• Operate independently with minimal guidance in PQS role.
• Mentor less seasoned CoE members and participate in cross-functional meetings.

Responsabilités

• Stability management oversight from late development to commercial lifecycle.
• Lead stability-related activities and ensure data quality for regulatory filings.
• Collaborate with PQI/PQO/PQL and other functions to maintain Stability CoE effectiveness.
• Act as Stability SME for assigned product families with complex needs.
• Identify opportunities for process improvements and SOP enhancements.

Connaissances

Stability management

Regulatory knowledge

Cross-functional collaboration

Analytical reasoning

SOP interpretation

Formation

Bachelor's Degree

Outils

Microsoft Office

Web-based collaboration tools

Description du poste

Get 360Pharma is seeking a Product Quality Specialist to manage stability across late development to full commercial lifecycle for a portfolio of products in Europe. You will act as Stability SME, ensure regulatory alignment, and collaborate with PQI/PQO/PQL and other functions to maintain quality across the CoE.

You will work independently with minimal guidance, mentor junior team members, support stability data in regulatory filings, and drive continuous improvement in stability processes and