Senior Quality Assurance Associate

NES Fircroft; Breda; On-site; EUR 50,000 - 75,000; Full time

Benefits offered by this job

Outstanding shift allowances

Job summary

NES Fircroft is seeking a Senior Associate QA to provide hands-on quality support in a GMP manufacturing and packaging environment on-site in Breda. This role requires strong communication, quick issue resolution, and collaboration with Production, QA, and maintenance to ensure regulatory compliance.

You will review batch records, support deviations and investigations, and contribute to SOP updates and training initiatives.

Qualifications

• 3+ years of experience in Quality Assurance or pharmaceutical manufacturing.
• Experience reviewing batch records and supporting investigations.
• Solid knowledge of GMP, GDP and/or GCP and their regulatory applications.
• Experience in a regulated manufacturing environment.
• Fluent in English (written and spoken).

Responsibilities

• Provide daily QA guidance and compliance support to Production staff.
• Review and approve batch production record entries before production.
• Compile, review and finalize batch records for QP disposition.
• Perform routine GMP compliance checks on the production floor.
• Review and approve deviation records and act as deviation owner when needed.
• Support investigations, root cause analyses and corrective actions.
• Prepare and update SOPs and Work Instructions.
• Contribute to GMP training for QA and production personnel.
• Participate in QA projects and continuous improvement initiatives.
• Prepare weekly/monthly quality metrics and reports; maintain boards.

Skills

GMP knowledge

Quality assurance

Communication

Team collaboration

Education

Bachelor’s degree in Pharmaceutical Sciences or Life Sciences

MBO or equivalent

Job description

A leading global biopharmaceutical organization is seeking an experienced Senior Associate QA to provide hands‑on quality support within a GMP manufacturing and packaging environment. This role is based on site in Breda and operates within a 24/7 production setting.

We are looking for an outgoing, resilient, and highly communicative QA professional who thrives in fast‑paced environments, can manage multiple priorities, and is confident acting as a quality mediator on the production floor. GMP experience is highly desirable.

This is a mandatory 3‑shift role with 100% commitment required.

Shift rotation

• 1 week night shift
• 1 week late shift
• 1 week early shift
• 1 week late shift
• 1 week early shift
• Early: 06:30 – 15:00
• Late: 14:30 – 23:00
• Night: 22:30 – 07:00

Outstanding shift allowances apply.

Role Objectives

• Provide QA guidance and real‑time support to production operations.
• Perform batch record review for batches assembled, packaged, and labeled on site.
• Build strong working relationships with Production, Warehouse, Maintenance, Engineering, QA Management, and the Qualified Person (QP).

Key Responsibilities

• Provide daily QA guidance and compliance support to Production staff in accordance with SOPs and Work Instructions.
• Act as first point of contact for quality‑related production queries during packaging and labeling operations.
• Review and approve batch production record entries prior to execution of production activities.
• Compile, review, and finalize batch records in preparation for QP disposition.
• Perform routine GMP compliance checks on the production floor.
• Review, initiate, and approve deviation records; act as deviation owner when required.
• Support investigations, root cause analyses, and follow‑up actions.
• Author, review, and update operational SOPs and Work Instructions as needed.
• Support development and delivery of GMP training for QA and production personnel.
• Participate in QA‑related production projects and continuous improvement initiatives.
• Prepare weekly and monthly quality metrics and reports.
• Own and maintain departmental performance boards.

Knowledge & Professional Expertise

• Strong understanding and application of GMP principles, concepts, and standards.
• Specialized quality or manufacturing knowledge within own discipline.
• Good awareness of regulatory and industry compliance requirements.
• Experience handling data integrity issues and ensuring regulatory compliance.

Problem Solving & Autonomy

• Applies analytical and interpretation skills to quality‑related problems of moderate complexity.
• Develops practical and compliant solutions within defined regulatory frameworks.
• Works under general direction, guided by departmental objectives.
• Recognizes issues early and escalates appropriately.
• May define priorities and timelines for assigned tasks and projects.
• Ensures high‑quality delivery of assigned QA tasks and responsibilities.
• Supports achievement of departmental milestones and production goals.
• Acts as a QA resource for colleagues and provides guidance or training when needed.
• Builds effective working relationships across departments and functions.

Requirements

• MBO or Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, or a related field
• (or equivalent combination of education and experience)
• Typically 3+ years of experience in Quality Assurance or pharmaceutical manufacturing.
• Experience reviewing batch records and supporting investigations.
• Solid knowledge of GMP, GDP and/or GCP, with the ability to apply these principles in routine operational situations.
• Experience within manufacturing and/or quality operations in a regulated environment.
• Fluent in English (written and spoken).
• Willing and able to work a full 3‑shift rotation.