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Job Title: QA Specialist (Batch Record Review / GMP)

Salary: Up to 58,230€ per year

Location: Hoofddorp Area, Netherlands

Work Model: Full-Time, On-site

New QA Specialist opportunity at a leading Pharmaceutical Company developing cutting edge immunotherapy at their facility in Hoofddorp.

Working with the Quality Assurance team, you'll use your Batch Record Reviewing, GMP experience and keen eye for detail to ensure the quality and compliance of cutting-edge cancer immunotherapies saving patients lives all over the world.

Offer:

• Salary: Up to 58,230€ per year
• Contract Type: Initial 12 month contract, with intent to become permanent.
• Work Model: Full-Time, On-site, 40h per week

You can expect:

• Career Growth: Opportunity to develop within a leading global biotechnology company.
• Impactful Work: Play a crucial role in the release of potentially life-saving cell therapies for cancer patients.
• Dynamic Environment: Work in a state-of-the-art facility within a collaborative and mission-driven QA Operations team.

Your Impact & Responsibilities:

As a QA Specialist I in the Operations Review & Disposition team, you are essential for ensuring product quality and compliance prior to release.

This includes:

• Batch Record Review:

Meticulously review manufacturing batch records (MBRs), environmental monitoring (EM) data, and Quality Control (QC) data (for in-process and finished products) in both paper and electronic formats (EBR).

• Compliance Verification:

Ensure all reviewed data and processes comply with current Good Manufacturing Practices (GMPs) and established internal procedures.

• Deviation Identification:

Identify and report any deviations, discrepancies, or departures from approved processes and procedures to senior colleagues, demonstrating an ability to recognize issues.

• Disposition Preparation:

Compile comprehensive product binders and documentation packages in preparation for final QA disposition and Qualified Person (QP) release of Advanced Therapeutic Medicinal Products (ATMPs).

• System Utilization:

Utilize various computerized systems (e.g., ERP, EBR, LIMS) to support record reviews and documentation.

• Administrative Support:

Perform administrative tasks as needed to support team functions.

Qualifications and Experience

• Experience & Education:

BSc degree AND 2+ years of experience in a GMP environment, OR Associate Degree (e.g., MBO/HLO level) AND 3+ years of experience in a GMP environment.

• Document Review Experience:

Demonstrable experience reviewing operational documents (e.g., Batch Records, Logbooks) within either a QA or Manufacturing (MFG) role is essential. (Must be evident in CV).

• Digital Affinity:

Experience with or a strong affinity for working with digital dossiers / Electronic Batch Records (EBR) is required. (Must be evident in CV).

• GMP Knowledge:

Basic understanding of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Technical Skills:

Working knowledge of Microsoft Office applications; familiarity with ERP, EBR, and/or LIMS systems.

• Communication:

Good verbal, written, and interpersonal communication skills in English.

• Mindset:

Detail-oriented, accurate, practically minded, and able to recognize deviations from standard practice.

• Preferred Qualifications:

Prior experience specifically in the pharmaceutical or biotechnology (especially cell therapy) industry.

Hands-on experience with specific ERP systems like EBS, SAP, Trackwise, or MES.

Interested?

Apply now! Feel free to contact:

Audrey Poluakan, Recruitment Consultant at Gi Life Sciences Netherlands

Email: audrey.poluakan@grafton.com

M: 0658069570