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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

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