Within our production environment, you make the difference as a QA Officer Level 1. You are the guardian of quality, ensuring that processes, systems, and products meet the highest GMP standards. With your expertise, you directly contribute to the safe production of high-quality pharmaceutical and biological products that reach patients worldwide.
Your Challenge
As a QA Officer Level 1, you are part of the Center of Excellence Quality Operations (CoE QO). This organization plays a crucial role in ensuring quality across all production activities, from the receipt of raw materials to the distribution of the finished product.
You work closely with the Qualified Person, Operational Coaches, (Senior) Operators, and colleagues within Improvement teams. In this role, you report to the QA-IPT Lead and act as an important sparring partner for operations in matters of quality and compliance.
What Will You Do?
In this role, you combine quality assurance with advisory and collaboration. You support the organization in continuously improving processes and ensure that everything meets the applicable GMP guidelines.
Validation & Qualification
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Act as a quality expert during qualification and validation activities.
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Assess and approve qualification and validation protocols.
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Approve validation and qualification reports.
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Provide advice on installation, qualification, and validation of equipment.
Deviations & Change Management
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Support root cause analyses for deviations.
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Assess and approve investigations, conclusions, and documentation.
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Approve corrective and preventive actions (CAPAs).
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Evaluate and approve changes within processes and systems.
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Involve the Qualified Person or QA specialist in a timely manner if deviations could impact product quality, patient safety, or compliance.
Documentation & Batch Review
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Review and approve master batch records.
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Review batch production and batch filling instructions.
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Ensure documentation complies with GMP requirements, internal quality standards, and registration documentation.
