Validation and Compliance Specialist- GMP/Pharma Industry

What You Will Achieve

In this role, you will author, review, and/or approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.

• Perform a variety of Validation activities in compliance with Good Manufacturing Practices (GMP) and Validation Master Plan (VMP) requirements.
• Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
• Manage routine Quality systems such as Supplier Quality Management, Change Control, Quality Risk Management, Documentation, and Investigations, Annual Product Review and coordinate testing with functional groups.
• Maintain the Site Validation Master Plan and support validation as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility.
• Support regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BS with at least 2+ years of experience in pharmaceutical industry
• Proven expertise in Good Manufacturing Practices
• Strong working knowledge of various quality systems and processes
• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
• Excellent verbal and written communication skills
• Ability to work independently and in a team environment

Bonus Points If You Have (Preferred Requirements)

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
• Experience with quality management systems like Veeva and Kneat
• Strong analytical and problem-solving skills
• Strong organizational and time management skills
• Ability to mentor and guide other colleagues
• Experience in regulatory audits and compliance
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
• Technical writing skills