Product Quality 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

We are searching for the best talent for a Product Quality Specialist to be based in Belgium, Netherlands, Ireland, or Italy.

You will be responsible for:

• Has end-to-end accountability for the stability management and oversight from late stage development through full commercial lifecycle for a portfolio of products.
• Responsible for product quality related activities with a specific expertise in stability.
• Supporting the work of PQI/PQO/PQL and actively contributing to overall smooth functioning of the Stability CoE
• Be expert in specific areas of stability management
• Operate independent in the PQS role with minimal support
• Support departmental goals and activities
• PQS for Product families that are highly complex or L&G of high value requiring interactions with multiple functions and teams.
• Identify opportunities for improvement
• Mentor less seasoned members of CoE
• Participate in cross-functional meetings as needed
• Support stability related escalations as needed
• Support regulatory filings with stability information/data.
• Responsible for stability Protocols/reportsStability SME for assigned product, manage temp excursions, CC etc.

Qualifications/Requirements:

• 6-8 years of industry experience
• Education Bachelor’s Degree
• Ability to work with others in a team environment
• Ability to manage individual assignments with minimal guidance
• Ability to read and interpret documents such as SOPs, work instructions, protocols
• Clear knowledge of stability related regs
• Proficient with using Microsoft office applications and web-based collaborative applications

Preferred Skills:

• Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)