Key Responsibilities:

• Lead and support Out of Specification (OOS) investigations and root cause analysis activities.
• Perform QC compliance gap assessments against relevant pharmacopoeial and regulatory requirements.
• Support method optimisation, verification, validation, and transfer activities.
• Review validation, stability, and risk assessment reports.
• Prepare and review technical transfer protocols and reports.
• Participate in CAPA implementation, change controls, and continuous improvement programmes.
• Support audit readiness activities and contribute during regulatory and customer audits.
• Contribute to New Product Development (NPD) & QC projects.
• Provide coaching, training, and technical support to colleagues while deputising for Team Leaders when required.

Required:

• A degree in Microbiology or similar relevant filed / equivalent relevant scientific experience.
• Significant experience within a GMP Quality Control laboratory environment.
• Strong microbiology skills, with practical experience in performing; Preservative Efficacy Testing (PET), total viable counts, environmental monitoring, and water testing.
• Strong understanding of analytical testing, method validation, and compliance requirements.
• Proven experience leading invesigatiotns, CAPAs, and continuous improvement initiatives.

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