Role Summary:
We are seeking an experienced professional to join our team in a Quality & Regulatory Compliance Specialist position.
The ideal candidate will be responsible for ensuring compliance with Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations.
* Maintain regulatory licenses and manage pharmacovigilance and vigilance activities
* Handle audits and CAPAs, and ensure up-to-date documentation and training programs
* Support compliance with MDR/IVDR, oversee change control processes, and ensure products meet quality standards before distribution
Key Responsibilities:
Quality Management & Compliance:
* Oversee GDP activities for pharmaceutical and medical device products
* Ensure temperature control and environmental monitoring of storage and distribution areas
* Manage quality operations, including deviation/NC handling, root cause analysis, and implementation of corrective and preventive actions (CAPAs)
* Perform risk assessments for distributed products and processes in line with regulatory and company standards
* Maintain and control documentation, including SOPs, records, and batch release documents
Regulatory:
* Prepare, submit, and maintain facility licenses, registrations, and renewals with national and international regulatory bodies
* Oversee compliance with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements
* Monitor regulatory updates and assess business impact (regulatory intelligence)
* Review and approve product labeling, promotional materials, and advertising to ensure regulatory compliance
Pharmacovigilance & Safety:
* Manage pharmacovigilance and medical device vigilance activities, including adverse event reporting and follow-up
* Handle product complaints and coordinate recalls in line with regulatory expectations and internal procedures
Validation & System Control:
* Oversee validation of systems, equipment, and processes involved in distribution
* Ensure compliance with data integrity
Training & Development:
* Develop, maintain, and deliver training programs to ensure all staff comply with GDP, GMP, and quality policies
* Ensure training records are complete and up-to-date
Supplier & Warehouse Oversight:
* Qualify and manage suppliers and third-party service providers, including audits and performance monitoring
* Support warehousing operations to ensure GDP compliance, including good housekeeping, pest control, and material handling
Product Release:
* Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution
Change Control:
* Manage the change control process for systems, products, and procedures, assessing potential risks and regulatory impacts