Quality Officer/Specialist

☞ DPS Group Global

Visualizza: 135

Giorno di aggiornamento: 16-11-2025

Località: Geel Antwerp

Categoria: Garanzia di qualità / Controllo di qualità

Industria: Pharmaceutical Manufacturing

Posizione: Mid-Senior level

Tipo di lavoro: Full-time

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Contenuto del lavoro

Key Responsibilities (may differ among employees with same job title and may change over time in accordance with business needs):

• The SCES Q Contract Manufacturing Quality Specialist acts as the day-to-day liaison with internal

and external customers for quality related activities.

• Ensure GMP compliance of products manufactured and/or tested at a contract facility.

• Ensure all aspects of product manufacturing and/or testing are reviewed versus established

quality standards and the applicable marketing authorizations.

• Manage quality systems, e.g. change control, deviations, complaints, and product investigations.

• Modify, review, and ensure contractor quality standards and protocols for processing materials

into partially finished or finished product meet internal and GMP requirements.

• Contribute to the completion of milestones associated with specific projects.

Core Responsibilities:

• Release product in accordance with approved specifications and procedures.

• Monitor contractor compliance via GxP documentation review and on-site visits/audits.

• Implement methods and procedures for inspecting, testing, and evaluating the precision and

accuracy of products and production equipment.

• Compile data and write summaries for periodic product reviews, investigations, complaints, and

deviations.

• Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter

Expert review.

• Interact with multi-functional internal and external project teams to ensure compliance.

• Respond to technical and quality issues and handle schedule and/or process-related conflicts.

• Demonstrate understanding of applicable US and global regulations related to manufacture of

medicinal products (small molecules and biologics).

• Monitor contractor performance to established Key Performance Indicators (KPI) and report

adverse trends.

• Provide guidance to less experienced staff, as applicable.

Requirements:

• Bachelor’s or Master degree and 3-5 years of experience in a cGxP or other regulated environment, to include

• 3 years in a Quality role

• Excellent communication and organizational skills.

• Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time).

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Scadenza: 31-12-2025

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