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QA Lead

Supporting the Head of Quality Management in establishing a well-defined QMS robust enough to comply with regulatory requirements.

Supporting the development of SOPs to ensure regulatory compliance and pharma industry standards.

Investigating and reporting on deviations, executing root cause analysis, defining and implementing CAPA plans.

Identifying and utilising process improvement opportunities while fostering a culture of quality.

Developing and managing training materials, delivering training and overseeing all training workflows while managing and coordinating onboarding and offboarding.

Providing guidance, support and supervision on the pragmatic interpretations of GxP, Standard Operating Procedures (SOP), quality management and regulatory compliance.

Helping developing and maintaining quality assurance metrics to oversee how the units are performing with respect to quality.

Managing the corresponding part of internal QA audits, partially utilising risk-based methodologies.

Planning and conducting audits:
System, process and facility audits
Vendor and Supplier audits

Facilitate, host and co-ordinate regulatory authority inspections.

Liaising with client sponsor auditors and regulatory inspectors on the follow-up of findings.