QA Project Engineer MES
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Our client, a leading pharmaceutical organization focused on innovative therapies, is seeking a QA Project Engineer MES to join their digital quality team. This role is responsible for overseeing quality deliverables to ensure compliant manufacturing through advanced electronic systems.
- Provide QA oversight of MBR verification activities in alignment with approved procedures and timelines.
- Review MBR checklists, design documentation specifications, and testing strategies for electronic master batch records.
- Review executed verification protocols and supporting evidence, ensuring resolution of all comments.
- Review traceability matrices, PQ documentation, and project quality plans to ensure inspection readiness.
- Support quality and data-integrity oversight of MES elements and electronic batch records.
- Confirm that all deliverables meet GMP and internal procedural requirements.
- Identify and follow up on risks, deviations, and corrective actions throughout the project lifecycle.
- You possess a Bachelor or Master degree in bio-engineering, pharmacy, or a relevant scientific field.
- You bring 3+ years of cross-functional experience within the pharmaceutical industry.
- You have sound knowledge of cGMP requirements and relevant pharmaceutical regulations.
- You possess hands-on experience with QA and master batch records in a GMP production environment.
- You're analytical and communicative with a practical, solution-oriented mindset.
Nice to Haves
- Experience reviewing MBR verification or qualification documentation.
- Practical experience with MES systems such as PAS-X or Opstracker.
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