Job Overview
As a Computer Systems Validation & Compliance Specialist, you will play a crucial role in ensuring the quality and integrity of our pharmaceutical products. This position requires a strong understanding of regulatory requirements and compliance with industry standards.
Key Responsibilities:
* Manage regulatory compliance programs and ensure adherence to policies and procedures
* Promote a risk-based and efficient approach to compliance activities
* Collaborate with site compliance and validation teams to coordinate activities
* Ensure compliance with Computer Systems Validation, Systems Development Lifecycle, Cyber Security, and Data Integrity
* Act as a Subject Matter Expert on computer validation for capital projects
Requirements:
* Bachelor's Degree in Computer Science, Engineering, Regulatory Compliance, or a related field
* 2+ years of experience in compliance activities for capital projects
* Strong knowledge of regulatory requirements related to computerized systems validation
* Familiarity with ISA S95 and S88 Standards in a Good Practice environment
Preferred Qualifications:
* Postgraduate qualification in Business Strategy or IT Architecture
* Experience in the pharmaceutical industry, particularly in Manufacturing and Supply Chain
What We Offer:
* Opportunity to work in a dynamic and innovative environment
* Chance to develop your skills and expertise in compliance and validation
* Collaborative team environment with opportunities for growth and development