Sr. QA Executive

The Senior QA Executive plays a crucial role in overseeing various aspects of quality management within the organization. This includes but is not limited to document control, compliance monitoring, internal audits, quality metrics tracking, and non-conformance management. The position also involves contributing to change control, supplier evaluation, risk management, product and process validation, complaint handling, CAPA support, and quality improvement projects. A key part of the role is to engage in data entry, analysis, and report preparation to ensure alignment with quality and compliance objectives. Responsibilities of the role include: - Document Control: Assisting in the organization and maintenance of quality documentation such as the Quality Manual, Documented Procedures, Standard Operating Procedures (SOPs), and forms. - Internal Audits: Participating in internal audits across various departments to evaluate compliance with the Quality Management System (QMS) and providing reports to senior QA staff. - Non-Conformance Management: Supporting the investigation of non-conformities or deviations, including root cause analysis and the development of corrective and preventive actions (CAPAs). - Change Control Support: Aiding in the change control process by reviewing change requests and assessing their impact on quality and compliance. - Risk Management Assistance: Collaborating with senior QA staff to conduct risk assessments and implement risk management strategies. - Product and Process Validation Support: Participating in activities related to product and process validation to ensure they meet specified requirements. - Complaint Handling Support: Assisting in the review and resolution of customer complaints pertaining to product quality. - Corrective and Preventive Action (CAPA) Support: Supporting CAPA processes by collecting data and monitoring the progress of corrective actions. Candidates for this role are expected to have a Bachelor's or Master's degree in a life science background and ideally possess 2 to 4 years of relevant experience in a similar role within the IVD industry. Interested candidates are encouraged to share their CVs with hr2@athenesedx.com to be considered for this position.,