QA Associate

• Overseeing all training activities to ensure team competency and compliance. Help in Conducting audit planning and executing audits of various applications and departments.
• Reviewing validation documents to ensure compliance and accuracy.
• Performing peer reviews of audit plans, reports, and observations, and effectively communicating with auditors to clarify findings, ratings, and supporting evidence.
• Managing change requests, deviations, quality issues, CAPA (Corrective and Preventive Actions), effectiveness checks, and conducting root cause analysis.
• Assisting in the development of Key Performance Indicators (KPIs) for Quality Management System (QMS) performance monitoring and management oversight.
• Supporting the continuous improvement and operational success of the quality assurance function.
• Perform the assigned activities given by them as defined in the SOP

• Ensure that QA practices and deliverables comply with regulatory requirements and industry standards.
• Oversee the planning, execution, and documentation of all QA activities, including functional testing, regression testing, performance testing, and validation testing.
• Collaborate with development teams to identify and resolve defects and ensure the timely delivery of high-quality software releases.
• Collaborate with stakeholders to develop validation plans and protocols, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT).
• Prepare and maintain validation documentation, including validation plans, protocols, reports, and traceability matrices, in compliance with regulatory requirements and internal procedures.
• In-depth knowledge of regulatory requirements and guidelines governing CSV, including FDA regulations (21 CFR Part 11, 21 CFR Part 210/211), GxP, GAMP, Annex 11, and other relevant standards (e.g., ISO 27001, ISO 9001).
• Strong analytical and problem-solving skills, with the ability to interpret and apply regulatory requirements to validation activities and systems.

Qualifications:

• Strong understanding of quality assurance processes and regulatory requirements.
• Excellent analytical and communication skills.
• Ability to work collaboratively within a team and manage tasks effectively.
• understanding QA terminologies, exposure to any QMS database will be of added advantage