Senior Quality Assurance Engineer

10 hours ago

india beBeeValidation Full time

Job Title: Quality Assurance Specialist About the Role:We are seeking a highly skilled QA Validation Manager to lead validation activities across systems, equipment, and processes. This role ensures compliance with regulatory standards such as cGMP, FDA, and ISO, and plays a critical part in maintaining product quality and operational integrity. Responsibilities:Responsible for the activities related to validation/calibration compliance at shop floor and reporting to the HOD-Quality Assurance.Preparation of quality documents like validation master plan, validation protocol and executive summary reports etc.Planning and monitoring for timely completion of all calibration activities for instrument, equipment and any other supporting systems as per the master calibration plan/calendar.Responsible for documentation compliance (PQ) of the new instruments/equipments and execution of equipment validation master plan as per the pre-determined schedules on periodic basis.Updating daily activities, observations and document status to immediate supervisor.Any other activities as assigned by reporting employee.Review, retrieval, archival and destruction of all plant-related executed documents.Coordination and handling of external audits. Requirements:To be successful in this role, you will need to have:Bachelor's or Master's degree in Engineering, Life Sciences, or related field.Minimum 5–14 years of experience in validation and quality assurance, preferably in a regulated industry (Required Pharma experience candidates).Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.Experience with equipment qualification, process validation, and computerized system validation.Excellent project management and leadership skills.Proficiency in validation lifecycle documentation and risk-based approaches. Preferred Skills:Familiarity with validation software tools and electronic documentation systems, experience in regulatory audits and CAPA management, strong analytical and problem-solving abilities, effective communication and stakeholder management. Key Qualifications:This role is ideal for a motivated individual who is looking to take their career to the next level in a dynamic and challenging environment. If you are a detail-oriented professional with excellent communication skills, we encourage you to apply.

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