Regulatory Compliance Specialist

1 day ago


Singapore SUNWARD PHARMACEUTICAL PRIVATE LIMITED Full time
Roles & Responsibilities

Job Overview

As a Regulatory Compliance Specialist at SUNWARD PHARMACEUTICAL PRIVATE LIMITED, you will be responsible for ensuring the entire operational aspects of the company adhere to established SOP, GMP, GDP, and GLP practices and regulatory requirements.

Key Responsibilities

* Handling issues from cross-functional departments like QC/Production/Warehouse/Engineering
* Ensuring procedures and practices are adhered to in accordance with cGMP requirements
* Conducting Risk Assessment, collecting samples during validation processes, and qualification
* Involving and providing expertise in vendor audits, evaluation/qualification, and assessment
* Ensuring proper execution of validation (IQ, OQ, PQ, etc.)
* Providing advisory on Corrective and Preventive Action (CAPA) arising out of External/Internal audits, Unusual Occurrences/Incidents, Failures, and Market complaints
* Providing advisory on documentation and management of deviations, critical process steps parameters

Requirements

* Management Skills
* Vendor Audit
* CAPA
* Risk Assessment
* Ambulatory Care
* Treatment
* Inventory
* Healthcare
* GMP
* Purchasing
* Counseling
* Administration
* Compounding
* Audits
* Nursing
* Regulatory Requirements
* GLP

About Us

SUNWARD PHARMACEUTICAL PRIVATE LIMITED is a leading pharmaceutical company committed to delivering high-quality products and services. We are seeking a highly skilled and experienced Regulatory Compliance Specialist to join our team.

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