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Assistant Quality Assurance Manager
2 weeks ago
Position Name: Assistant Manager/Manager Quality AssuranceRole Description:Position will be responsible for QA function. Develop, implement and maintain the Quality Management System (QMS) at Scitara;Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements and establish the training function within ScitaraKey Responsibilities:Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirementsResponsible for authoring, reviewing and approving Standard Operating Procedures, Work Instructions, Policies, Manuals and Guidance documents for ScitaraRepresent Scitara in customer audits, regulatory inspections and certification audits (ISO 27001 and SOC II Type 2)Responsible to ensure education and awareness about audit/inspection readiness in the organizationImpart training on SOPs and regulationsManage CAPAs and deviations at an organizational levelEnsure that software systems meet regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5).Provide QA oversight for all phases of validation (planning, testing, deployment, and change control).Review and approve validation deliverables (e.g., Validation Plan, Test Plan, Test Scripts, Traceability Matrix, Validation Summary Report).Implementing the data privacy policies and associated processes in Scitara across functional units.Educational Qualifications: Bachelor’s or Master’s degree in appropriate field of studyExperience:IT CSV QA candidate with 08 – 10 years’ experience in QA, IT and Computer System validation with some background of Software Development. Expertise in validation principles and validation types, software development best practices, and quality management systems used in the FDA/MHRA/EMA regulated environments is required. Preferably, candidates who have worked / supported Pharma / Life Sciences companies.Desired Skills:Knowledge and understanding of GxPs and other governing regulations, both local and internationalUnderstanding of quality systems processes and their implementationStrong written and verbal language skillsConcern for qualityAttention to detailPlanning and prioritizingLocation: Mumbai/Pune
