Are you ready to accelerate your potential and make a real difference in life sciences, diagnostics, and biotechnology?
At Cytiva, one of Danaher’s 15+ operating companies, we are committed to innovation that saves lives. Our work supports customers involved in biological research, vaccine development, new medicines, and cell and gene therapies.
If you’re looking to work on challenges that truly matter, in a company that values continuous improvement and a culture of belonging, this opportunity is for you!
Job Details
📌 Position: QA CSV / QMS Specialist
📍 Location: Bangalore, Karnataka, India
🗂 Category: Quality & Regulatory Affairs
📌 Job ID: R1284933
What You’ll Do
As a QA CSV / QMS Specialist, you will:
- Provide Computerized System Validation (CSV) support for key global projects, ensuring compliance with QMS and regulatory requirements.
- Review and approve GxP assessments, Validation Master Plans, and validation lifecycle documentation.
- Support GxP system applications as a QA CSV representative by reviewing, approving, and authorizing change controls.
- Work closely with the Biopharma QARA CSV IT and IT Compliance Manager to implement CSV training and education programs.
- Provide input, review, and approve quality records related to CSV, including Deviation, Change Controls, and CAPAs.
- Ensure risk-based implementation of the CSV system in line with regulations.
- Support Document and Training Management from a global QMS perspective.
Who You Are
✅ Education & Experience:
- Bachelor’s Degree with 5+ years of experience in regulated medical devices, pharmaceuticals, or life sciences in Quality or CSV-related roles.
- Experience in Quality Assurance / Quality Engineering in CSV within a GMP environment.
✅ Technical Expertise:
- Proficiency in GAMP 5 and knowledge of FDA/EU regulations.
- Understanding of Medical Device QMS and regulatory standards such as:
- FDA CFR 21 820 (advantageous)
- ISO 13485, ISO 9001
✅ Skills & Competencies:
- Strong analytical, problem-solving, and root-cause analysis skills.
- Excellent organizational, presentation, and report-writing skills.
- Strong written and verbal communication; experience in global teams is a plus.
- Prior experience in IT system validation is an added advantage.
- Ability to prioritize tasks and meet critical deadlines.
Why Join Cytiva?
At Cytiva, we:
- Innovate at the speed of life to solve complex healthcare challenges.
- Foster a collaborative culture where diverse perspectives drive real impact.
- Operate within Danaher’s system of continuous improvement, turning ideas into reality.
How to Apply?
📢 Join our winning team today! Be part of a company that partners with customers worldwide to advance science and technology.
For more details, visit www.danaher.com.
🚀 Apply now and take your career to the next level!