We are currently seeking an Assistant Manager - QA to join our growing team. In the role you will be responsible for:
- Planning, scheduling, conducting, and closing audits that include projects, systems, processes, vendors, etc. as assigned. Assess, compliance to applicable regulations/guidelines, customer requirements, SOPs, and project instructions/guidelines during the audit
- Preparing for and hosting inspections and client audits, as assigned
- Supporting with qualification, periodic surveillance, and management of vendors
- Evaluating and effectively managing SOP deviations, quality issues, and complaints.
- Reviewing and approving the investigations, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and Effectiveness Check (EC) plans.
- Evaluating policies and procedures for compliance with applicable regulations/guidelines and provide recommendations for continuous process improvement.
- Providing interpretations and consultation to project teams on regulations, guidelines, policies, and procedures
- Ensuring compliance to training and conduct training to staff within and outside QA, as assigned.
- Support the effective implementation and maintenance of Quality Management Systems
- Lead and support with departmental activities and QA initiatives
Desirable Skills and Experience
- QA Audits
- Clinical Trial Audits
- Sponsor Audits
- Site Audits