QA Associate (Shifts)

SIRE LIFE SCIENCES; Breda; On-site; EUR 42,000 - 58,000; Full time

Job summary

SIRE LIFE SCIENCES in the Netherlands is seeking a QA Associate to provide onsite Quality Assurance support within the production area. You will be a key contact for quality matters, ensuring GMP compliance and reviewing batch documentation for products assembled, packaged and labeled for distribution.

You will perform in-process and finished product checks, compile batch records for QP disposition, support deviation handling, and contribute to SOP development and QA training for production

Qualifications

• MBO or BSc in Life Sciences, Pharmaceuticals, or related field.
• Minimum 3 years QA/manufacturing in pharma or regulated industry.
• Fluent in English; GMP/GDP/GCP knowledge.

Responsibilities

• Provide daily QA guidance to ensure SOP and work instruction compliance.
• Be first contact for quality questions during packaging and labeling.
• Review and approve batch production record entries before production.
• Perform in-process and finished product checks.
• Compile and prepare batch records for QP disposition.
• Conduct GMP compliance checks and support deviation investigations.
• Author or review SOPs and support QA/training activities.

Skills

QA

GMP/GDP/GCP

Batch record review

Deviation handling

SOP writing/review

English fluent

Education

BSc Life Sciences

MBO Life Sciences

Job description

The Company

A leading global biotechnology organization, dedicated to developing and delivering innovative medicines to improve patient outcomes. Operating worldwide, the company combines science, technology, and quality-driven processes to ensure safe and effective clinical products.

Role Description

As a QA Associate , you provide onsite Quality Assurance support within the production area. You act as a key point of contact for quality related matters, ensure compliance with GMP standards, and review batch documentation for products assembled, packaged, and labeled, ready to be distributed.

Responsibilities

• Provide daily QA guidance in production areas to ensure compliance with SOPs and work instructions


• Act as first point of contact for quality related questions during packaging and labeling


• Review and approve batch production record entries prior to manufacturing activities


• Perform in-process and finished product checks


• Compile, review, and prepare batch records for QP disposition


• Conduct GMP compliance checks and support deviation handling


• Author or review SOPs and work instructions


• Support GMP training activities for QA and production teams

Requirements

• MBO or BSc in Life Sciences, Pharmaceuticals, or related field


• Minimum 3 years of experience in QA or manufacturing within pharma or other regulated manufacturing industries


• Experience with batch record review and handling deviations/investigations


• Strong understanding of GMP/GDP/GCP principles


• Fluent in English

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