Quality Assurance Analyst

4 weeks ago


Noida, India YD Talent Solutions Full time

Key Responsibilities :- Ensure compliance with GAMP 5 guidelines for system validation and development.- Create, review, and maintain SOPs, Policies, Guidelines, and Procedures related to quality assurance.- Perform internal audits and assist in preparing for and facing external audits (regulatory or client).- Ensure compliance with 21 CFR Part 11, EU Annex 11, GDPR, and other relevant global regulations.- Lead investigations and manage documentation for Deviations and CAPAs.- Support IT GxP system compliance, ensuring systems are validated and maintained per regulatory expectations.- Contribute to and support Computer System Validation (CSV) activities and documentation.- Provide oversight and support on Data Privacy and Data Security practices in IT systems.- Support ISO 27001 implementation and audits, including maintaining documentation and process adherence.- Ensure continuous improvement of quality processes and help maintain a robust quality management system (QMS).Required Skills & Qualifications : - Bachelors degree in Life Sciences, Computer Science, or a related field.- 3 - 4 years of experience in a QA role within a regulated environment.- Solid understanding of GAMP 5, CSV, and GxP practices.- Familiarity with data privacy regulations (e.g., GDPR).- Working knowledge of ISO 27001, 21 CFR Part 11, and EU Annex 11.- Experience in writing and handling Deviations, CAPAs, and participating in audit processes.- Excellent documentation, communication, and stakeholder management skills.- Strong attention to detail and analytical skills. (ref:hirist.tech)



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