Furqan Sadiq
Process Engineer | Quality Professional | Pharmaceuticals and Medical Device Industry
- Role
- Compliance Specialist at Regeneron
- Location
- Framingham, MA, US
- LinkedIn followers
- 500 followers
About Furqan Sadiq
Experienced Process Engineer in the pharmaceutical and medical device industry, adept at…
Experience
Compliance Specialist
Jun 2025 — Present · Albany, NY, US
Managed engineering change controls in compliance with cGMP, FDA, EMA, and internal quality systems.• Supported structured change management processes across the project lifecycle, contributing to the review, documentation, and implementation of design, execution, and readiness-related changes in collaboration with engineering, construction, and quality teams.• Coordinated evaluation, documentation, and approval of pre-Process Validation (Pre-PV) and operational readiness changes, partnering with cross-functional stakeholders to assess impact, manage risk, and maintain schedule and quality objectives.• Completed and reviewed process control and batch documentation supporting commercial production and approved change implementations in a GMP environment.• Reviewed protocols, technical reports, and change control documentation for accuracy, data consistency, and formatting to support execution, development studies, and regulatory approval.• Participated in cross-functional brainstorming to improve technical documentation, process design strategies, and change management execution supporting full-scale development.• Assisted in troubleshooting and provided compliance and floor support to the Process Control Development Team during batch activities, protocol execution, and implementation of approved changes.• Supported CAPA investigations by contributing to root cause analysis, protocol development, execution, effectiveness verification, and formal change control implementation.• Managed QMS platforms (Veeva Vault, Process Compliance) to document, track, and close change records supporting tech transfers, process updates, and compliant execution.• Maintained audit-ready change control documentation for sterile drug product manufacturing and technical transfer activities, ensuring adherence to FDA, EMA, and Health Canada regulations.
Education
University of South Florida
Master's degree
2021 — 2022
Ghulam Ishaq Khan Institute of Engineering Sciences and Technology
Bachelor's
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