Validation manager

11 hours ago

india VINS Bioproducts Limited Full time

Position Summary 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 c GMP, FDA, and ISO, and plays a critical part in maintaining product quality and operational integrityJob Description (Validation Manager)1 Responsible for the activities related to Validation / calibration compliance at shop floor and reporting to the HOD-Quality Assurance.2. Preparation of quality documents like validation master plan, validation protocol and executive summary reports etc.3. 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.4. 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.5. Updating daily activities, observations and document status to immediate supervisor.6. Any other activities as assigned by reporting employee. 7. Review, retrieval, archival and destruction of all plant related executed documents.8. Coordination and handling of external audits.QualificationsBachelor's or Master's degree in Engineering, Life Sciences, or related fieldMinimum 5–14 years of experience in validation and quality assurance, preferably in a regulated industry (Required Pharma experience candidates)Strong knowledge of c GMP, FDA, EMA, and ICH guidelinesExperience with equipment qualification, process validation, and computerized system validationExcellent project management and leadership skillsProficiency in validation lifecycle documentation and risk-based approachesPreferred SkillsFamiliarity with validation software tools and electronic documentation systemsExperience in regulatory audits and CAPA managementStrong analytical and problem-solving abilitiesEffective communication and stakeholder management

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