Quality Assurance Manager

We are seeking an experienced  Deviation, CAPA & Change Control Specialist  to support Quality and Compliance activities within a regulated GxP environment. The successful candidate will take ownership of deviation and CAPA management while supporting the effective assessment and implementation of change controls and other compliance-related activities.
The role requires strong expertise in pharmaceutical/biotech quality systems, with a proven ability to manage investigations, identify root causes, implement effective corrective and preventive actions, and ensure compliance with applicable procedures and regulatory requirements.

Key Responsibilities   Act as the  owner for minor and major deviations , ensuring timely and compliant management from initiation through closure.
Lead and/or coordinate  deviation investigations , including impact assessments, root-cause analysis and identification of appropriate corrective actions.
Manage  CAPAs , ensuring actions are appropriately defined, implemented, documented and closed within agreed timelines.
Monitor CAPA effectiveness and ensure actions address the identified root cause and prevent recurrence.
Support the  management of Change Controls , including impact assessment, documentation, implementation and closure.
Collaborate with cross-functional stakeholders to ensure deviations, CAPAs and changes are effectively assessed and implemented.
Provide support for  Quality and Compliance activities , ensuring adherence to internal procedures and applicable GxP requirements.
Ensure quality records and documentation are complete, accurate, traceable and inspection-ready.
Identify recurring issues and trends and contribute to continuous improvement of the Quality Management System.
Support audit and inspection readiness activities as required.
Provide expert guidance and advice on deviation, CAPA and change control processes.
Required Experience & Expertise   Proven experience in  Deviation Management, CAPA and Change Control  within a regulated GxP environment.
Strong knowledge of pharmaceutical/biotech  Quality Management Systems (QMS) .
Experience managing both  minor and major deviations  from initiation through final closure.
Demonstrated expertise in  root-cause analysis and investigation methodologies .
Experience developing, managing and assessing the effectiveness of CAPAs.
Good understanding of  GMP/GxP regulations and compliance requirements .
Strong stakeholder management and cross-functional collaboration skills.
Excellent organisational skills, with the ability to manage multiple quality activities and deadlines.
Strong written and verbal communication skills. xqziphu
Ability to work independently, take ownership and drive quality issues through to successful resolution.