Internal Operations QA Specialist
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Our client, a leading biopharmaceutical organization, is seeking a professional to support their biological development activities. This role combines operational shop floor presence with administrative quality assurance tasks to ensure compliance during the manufacturing of early-stage biologics. The project requires high adaptability in a dynamic environment where priorities can change frequently.
- Participate in daily interactions and meetings with production teams on the manufacturing floor.
- Follow manufacturing activities and monitor batches in real time to maintain compliance.
- Perform batch record reviews and manage deviations within the quality system.
- Execute GMP floor checks, compliance tours, and mini-audits when required.
- Collaborate with stakeholders to solve quality issues and manage CAPA and change control processes.
- Handle technical documentation including SOPs, protocols, and reports.
- You have a Bachelor or Master degree in a scientific discipline.
- You bring 3+ years of experience in a GMP environment.
- You possess experience with quality systems including deviations, CAPA, and change control.
- You're autonomous, proactive, and able to manage multiple priorities in a dynamic environment.
- You have strong teamwork and communication skills.
- You have a basic knowledge of English.
Nice to Haves
- Previous experience in biologics production or the pharmaceutical industry.
- Strong knowledge of regulatory requirements.
- Comfort with stakeholder management and interest in continuous improvement.