Quality Specialist

3 days ago


Mumbai, India Adalvo Full time

At Adalvo, we're not just a company - we're a team of passionate individuals driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, we are fast, we are always on target, we are AdalvoWe are looking for an enthusiastic Quality Assurance Specialist to join our dynamic Quality s team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.SUMMARY OF POSITIONThe Quality Assurance Specialist will provide support to QA team by contributing to all activities involving quality assurance and compliance with applicable regulatory requirements and assuring that Company standards are maintained, and product integrity is preserved.RESPONSIBILITIESPrimary responsibilities of this role include the following:- Supporting in the maintenance of internal quality systems and GxP activities.- Supporting in the drafting, reviewing, issuing and archiving of GxP documents.- Ensuring that documents issued are incompliance with good documentation practices.- Preparing and reviewing SOPs related to Adalvo operations- Providing support to Quality team in the handling of deviations, change controls, CAPAs, complaints and risk assessments.- Assisting in internal and external audits and in the preparation of corrective and preventive actions (CAPA) and their respective follow up.- Supporting and assisting in training activities and monitoring SOP training gaps.- Supporting and assisting the QP/RP in qualification of vendors and customers.- Supporting and assisting the QP/RP in review of distribution and release documentation.- Providing support in investigations related to deviations, complaints and recalls.- Supporting continuous improvement activities related to Adalvo.- Participating in quality management review meetings and assist in any follow upsrequired.- Keep abreast with latest requirements related to GMP and GDP.- Approve materials, vendors and customers in SAP after quality review.- Support in the


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