- At a minimum, following activities are required to be performed;
- Validation and Qualification activities for the infrastructure, systems and processes for GxP compliance throughout GENINVO.
- Oversee the Organization’s quality assurance organization to insure efficiency, quality, service, and cost-effective management of resources.
- Work Closely with QA Manager on GxP audit programs for internal and external facilities as well as vendors and sub-contractors. This will include all study/project audits, any deviations, CAPA and subsequent reporting programs that advise the study/project director for potential impact.
- Work Closely with QA Manager on managing client issues and expectations with regards to organizational quality systems.
- Review of Project/Study documents for accuracy and completeness.
- Co-ordinate with the development staff to assure that the quality level and standard operating procedures within the organisation are implemented into the study/project from inception till end.
- Investigating customer complaints.
- Perform other roles and responsibilities as assigned by the senior management
SKILLS & EXPERIENCE
- Bachelor’s degree from a reputed university preferably in life science related fields
- Must have excellent knowledge of cGxPs, Quality standards, industry best practices and regulatory affairs for life sciences and IT processes.
- Expertise in regulatory affairs and requirements for clinical research processes.
- Sound knowledge of aspects of SAS programming, project management, pharmacovigilance systems, clinical data management, data submissions, clinical trial monitoring.
- Strong capability to execute audits, facilitate and drive investigations, root cause analysis, and corrective and preventive actions.
- Good understanding of quality and project management methodologies.
- Excellent knowledge of SDLC methodologies, software testing and validation & verification