Job Title

Role Overview:The QA Executive – Change Management will be responsible for managing and governing quality aspects of change control across systems, processes, equipment, and documentation. The role ensures that all changes are assessed, approved, implemented, and closed in compliance with regulatory requirements, internal quality standards, and GxP guidelines.Years of exp: 3-6 YearsLocation: HyderabadKey ResponsibilitiesChange Management (Primary Focus)- Manage end-to-end Change Control processes, including initiation, impact assessment, approval, implementation, and closure. - Review and assess changes related to manufacturing processes, systems, equipment, utilities, documents, and suppliers. - Ensure appropriate risk assessments (e.g., FMEA) are performed for proposed changes. - Coordinate with cross-functional teams (Manufacturing, Engineering, QC, Regulatory, IT) to drive timely change execution. - Monitor effectiveness checks and ensure post-implementation reviews are completed.Quality Assurance Responsibilities- Ensure compliance with GMP, GxP, and internal quality systems. - Review and approve SOPs, protocols, validation documents, and controlled records related to change activities. - Support deviation management, CAPA, and impact analysis linked to changes. - Participate in internal audits, regulatory inspections, and customer audits, with specific focus on change management controls. - Maintain accurate documentation within QMS / eQMS systems.Required Qualifications & Experience- Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related discipline. - 3-6 years of experience in Quality Assurance within Pharma / Biotech / Medical Devices. - Strong hands-on experience in Change Control / Change Management within a regulated environment. - Good understanding of GMP, ICH, WHO, USFDA, EU regulations. - Experience working with QMS / eQMS tools. - Ability to work cross-functionally and manage multiple changes simultaneously.