Senior Associate QA

Sire Search; Breda; Presencial; EUR 42.000 - 65.000; Jornada completa

Descripción de la vacante

Sire Search in the Netherlands seeks a NL CW Senior Associate QA to support GMP-compliant QA activities centered on SAP Master Data and artwork approval processes. The role ensures data integrity and collaborates with regulatory affairs, supply chain, master data specialists, and QA teams to drive continuous improvement.

The successful candidate will perform QA reviews, author SOPs, manage quality metrics, and participate in investigations while maintaining high quality standards in a regulated

Formación

• Bachelor degree or equivalent qualification in Life Sciences or a related field.
• Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience.
• Knowledge of GMP, GDP, and/or GCP regulations.
• Experience working within regulated pharmaceutical or medical device environments.
• Excellent communication and stakeholder management skills.
• Ability to work effectively under pressure.
• Experience with SAP Master Data processes is advantageous.
• Fluent English & Dutch language skills.

Responsabilidades

• Perform QA review and approval of SAP Master Data activities including critical value verification and Bills of Materials.
• Review and approve artwork for medicinal products.
• Author operational SOPs and Work Instructions.
• Conduct QA review of SOPs and Work Instructions.
• Participate in Quality Assurance projects and continuous improvement initiatives.
• Support investigations and issue resolution activities.
• Prepare weekly and monthly quality metrics reports.
• Own and maintain departmental performance boards.
• Monitor QA systems and recommend improvements.
• Collaborate with Global Artwork Center, Master Data teams, Site SMEs, Regulatory Affairs, and QA Management.
• Identify, evaluate, and resolve data integrity issues.
• Ensure compliance with regulatory and quality standards.

Conocimientos

Communication

Stakeholder management

Pressure handling

Educación

Bachelor's degree in Life Sciences or related field

Herramientas

SAP Master Data

Descripción del empleo

The Company

A global organization operating within the pharmaceutical and life sciences industry, focused on maintaining high quality standards across manufacturing, supply chain, and regulatory processes. The company works in a highly regulated environment where compliance, product quality, and patient safety are critical priorities.

About the Role

The NL CW Senior Associate QA is responsible for supporting Quality Assurance activities related to SAP Master Data and artwork approval processes. The role ensures compliance with GMP requirements while maintaining data integrity and operational excellence. This position works closely with cross functional teams including regulatory affairs, supply chain, master data specialists, and quality management to support business objectives and continuous improvement initiatives.

Responsibilities

• Perform QA review and approval of SAP Master Data activities including critical value verification and Bills of Materials
• Review and approve artwork for medicinal products
• Author operational SOPs and Work Instructions
• Conduct QA review of SOPs and Work Instructions
• Participate in Quality Assurance projects and continuous improvement initiatives
• Support investigations and issue resolution activities
• Prepare weekly and monthly quality metrics reports
• Own and maintain departmental performance boards
• Monitor QA systems and recommend improvements
• Collaborate with Global Artwork Center, Master Data teams, Site SMEs, Regulatory Affairs, and QA Management
• Identify, evaluate, and resolve data integrity issues
• Ensure compliance with regulatory and quality standards

Requirements

• Bachelor degree or equivalent qualification in Life Sciences or a related field
• Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience
• Knowledge of GMP, GDP, and/or GCP regulations
• Experience working within regulated pharmaceutical or medical device environments
• Excellent communication and stakeholder management skills
• Ability to work effectively under pressure
• Experience with SAP Master Data processes is advantageous
• Fluent English & Dutch language skills

59196