QA Operations Specialist

QA Operations Specialist – Batch Review

In this role, you are responsible for ensuring quality and compliance within a highly regulated pharmaceutical manufacturing environment. You act as a critical quality partner to Operations and play a key role in the timely and compliant release of products.

You work closely with Production, QA, and QC to ensure that batch documentation and processes meet applicable EU GMP and data integrity requirements.

What will you do?

• Review batch records and manufacturing documentation
• Evaluate deviations, investigations, and related quality documentation
• Perform risk assessments and assess impact on product quality
• Identify compliance gaps and escalate when necessary
• Collaborate closely with Operations on the shopfloor to strengthen quality oversight and process understanding
• Support timely and compliant batch release
• Apply and safeguard data integrity principles (ALCOA+)
• Contribute actively to continuous improvement initiatives within QA Operations

Who are you?

• Bachelor's or Master's degree in Life Sciences (Pharmacy, Chemistry, Biotechnology, Biochemistry, or equivalent)
• 2–4 years of experience in a GMP-regulated pharmaceutical manufacturing environment
• Proven hands-on experience in batch record review within QA Operations
• Strong knowledge of EU GMP requirements and data integrity (ALCOA+) principles
• Experience with deviation handling and quality documentation assessment
• Solid understanding of batch documentation, manufacturing records, and risk assessment methodologies
• Familiarity with ERP, MES, or electronic batch record (eBR) systems is a plus
• Experience in biologics or sterile manufacturing is a strong asset
• Analytical, critical, and detail-oriented
• Proactive and comfortable working in a fast-paced manufacturing environment

What we offer:

• A challenging QA role with direct impact on product release
• A key position within a GMP-regulated production environment
• Close collaboration with multidisciplinary teams on the shopfloor
• A competitive salary aligned with your experience and expertise
• An environment where quality, collaboration, and continuous improvement are central