IN_Senior Associate_CSV,QMS_RC - Internal Audit_Advisory_Noida
PwCNoida, Uttar Pradesh, India
Posted April 9, 2026
Full Time
About the Company
At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice, and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively.
Job Description
We are looking for a motivated and detail-oriented Associate-level professional to join our Validation team. The ideal candidate will have a foundational understanding of Computer System Validation (CSV) and Instrument Qualification within regulated environments such as pharmaceutical, biotech, or medical device industries.
Requirements
- Assist in the planning, execution, and documentation of Computer System Validation activities, including risk assessments, functional specifications, design specifications, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Support instrument qualification activities for laboratory and manufacturing equipment (IQ/OQ/PQ protocols) ensuring compliance with regulatory requirements.
- Participate in the review, update, and maintenance of validation-related documents, protocols, reports, and SOPs.
- Collaborate with cross-functional teams including Quality Assurance, IT, Manufacturing, and R&D to ensure systems and instruments meet compliance and operational requirements.
- Assist in performing gap analyses and impact assessments related to system changes or upgrades.
- Support internal and external audits by preparing documentation and responding to audit queries.
Benefits
- Flexibility programmes
