Harshali Pawar
Global Regulatory and Quality Assurance Specialist
- Role
- Regulatory Affairs Specialist at Sharp Sterile Manufacturing
- Location
- Pittsfield, MA, US
- LinkedIn followers
- 500 followers
About Harshali Pawar
I am a highly motivated and experienced Regulatory Affairs Specialist with a passion for…
Experience
Regulatory Affairs Specialist
Jan 2024 — Present · Lee, MA, US
The Regulatory Affairs Specialist is pivotal in supporting regulatory and client-related activities within the Quality Assurance department. This role ensures compliance with GMP (Good Manufacturing Practice) standards and regulatory requirements during client audits and inspections. Responsibilities include maintaining regulatory documentation, responding to client information requests, managing inspection readiness, supporting audit and inspection responses, contributing to Quality Agreements, investigating complaints, and assisting with regulatory submissions. The Specialist must ensure adherence to FDA regulations, 21 CFR 210 and 211, and other relevant standards, applying their knowledge of cGMPs to maintain quality operations and regulatory compliance.
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.