Swathi PS
Senior Quality Assurance Analyst
Berlin
Summary
Accomplished professional with over 7 years of experience in the pharmaceutical, healthcare, and biotech industries. Expertise in Computer System Validation (CSV), Quality Management Systems (QMS), and regulatory compliance. Certified QMS Lead Auditor with a proven track record of managing clinical data deliverables, leading cross-functional teams, and driving continuous process improvements. Adept at negotiating project timelines and resources, fostering strong customer relationships, and ensuring alignment with GxP and industry standards.
Overview
7
7
years of professional experience
2
2
Certifications
3
3
Languages
Work History
Senior Quality Analyst
Syngene International
01.2017 - 04.2024
- Managed CSV projects, ensuring validated systems met industry standards and regulatory guidelines
- Audited internal processes and systems as a certified QMS Lead Auditor, identifying and mitigating risks
- Collaborated with stakeholders to develop and optimize quality processes, achieving measurable improvements in compliance and efficiency
- Provided technical expertise and training to team members on validation processes and quality standards
- Served as the primary point of contact for clients on clinical data management deliverables, ensuring high-quality outcomes
- Led cross-functional teams to implement continuous process improvements, resolve escalations, and manage workload projections
- Negotiated project timelines, financial resources, and operational processes to meet client expectations and contractual obligations
- Conducted QMS audits and provided technical expertise to ensure compliance with regulatory requirements
- Fostered strong customer relationships, maintaining open communication to align expectations and drive project success
Education
Master of Science - Chemistry
Mangalore University
04.2001 -
Skills
Computer System Validation (CSV)
Quality Management Systems (QMS)
Lead Auditing
Clinical Data Management
Certification
Certified Quality Management Systems (QMS) Lead Auditor
Timeline
Senior Quality Analyst
Syngene International
01.2017 - 04.2024
Master of Science - Chemistry
Mangalore University
04.2001 -