Job Description

Job Summary:

The QA Validation Specialist is responsible for performing and overseeing cGMP-compliant validation and qualification activities related to equipment, facilities, and utilities within pharmaceutical manufacturing and drug product development. This role ensures that all systems are properly commissioned, qualified, and maintained in accordance with regulatory standards and internal procedures.

Responsibilities:

• Plan and execute equipment, facility, and utility qualification in compliance with cGMP regulations.
• Coordinate calibration and preventative maintenance schedules with internal teams and external contractors.
• Prepare and review validation documentation, including protocols, reports, SOPs, URS/FRS/DDS, FATs/SATs, and commissioning forms.
• Maintain validation master plans, environmental monitoring reports, and ensure documentation is current and audit-ready.
• Evaluate validation projects, develop test plans, and collect/analyze data for reporting and approval.
• Conduct gap assessments and remediation for legacy validation documentation.
• Support audits and inspections, including responses to FDA or client validation-related inquiries.
• Participate in deviation investigations, change control processes, and continuous compliance improvement efforts.

Qualifications:

• Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or related field.
• 1–2 years of experience in a pharmaceutical manufacturing environment (DPI, MDI, oral solid, or injectables preferred).
• Proficiency in Microsoft Office and quality/compliance software tools.
• Solid understanding of cGMP requirements, validation lifecycle, and regulatory compliance standards.
• Strong communication skills and the ability to work independently or as part of a cross-functional team.

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