Quality Assurance Analyst
2 weeks ago
Key Responsibilities :
- 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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