Amit Paira
Experienced in Computer System Validation, Ensuring Pharmaceutical Compliance & Quality.
- Role
- Associate Consultant at EY
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Amit Paira
Expert in Computer System Validation with a strong pharmaceutical industry background…
Experience
Associate Consultant
Feb 2024 — Present · Pune, IN
Develop and execute validation plans for computerized systems to ensure they meet the requirements of regulatory bodies such as the FDA, EMA, and other applicable guidelines.Collaborate with IT and quality assurance teams to define and document system requirements and specifications for both new and existing systems.Design and perform qualification tests, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to verify that systems are installed and operating according to their intended use.Conduct risk assessments to identify potential risks associated with computerized systems and implement mitigation strategies to address these risks.Prepare and maintain validation documentation, including validation protocols, test scripts, and validation reports, ensuring traceability and compliance with Good Documentation Practices (GDP).Stay current with industry trends and regulatory updates related to computer system validation to ensure ongoing compliance and best practices.Work with cross-functional teams to troubleshoot and resolve any issues arising during the validation process or routine use of the systems.Facilitate change control processes for computerized systems, ensuring that any changes are appropriately validated and documented.
Education
Seemanta Institute of Pharmaceutical Sciences (SIPS), Jharpokharia, Mayurbhanj
Bachelor of Pharmacy, Industrial and Physical Pharmacy and Cosmetic Sciences
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.