Product Quality Specialist

Il y a 4 jours

Beerse, Antwerpen, Belgique Get 360Pharma Temps plein 70 000 € - 95 000 € Contrat

Gratuit avec email ou Google

Enregistrez cette offre et organisez votre recherche

Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.

Gratuit avec email ou Google

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.

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

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)