Principal Specialist, QA Validation

Responsibilities

• Approve validation deliverables for cleaning, computer, equipment, process, analytical, and material evaluations to ensure regulatory compliance.
• Execute initial and final quality reviews of associated change controls and provide final approval of periodic reviews.
• Ensure validation and testing strategies are developed and followed to maintain compliance with regulatory, corporate, and industry guidelines.
• Support audits from Regulatory Authorities and Corporate auditors.
• Contribute to the development and improvement of validation quality systems, including policies, procedures, guidelines, and templates.
• Develop and present training materials to grow technical knowledge within functional areas.

Requirements

• Bachelor’s degree in engineering or a related scientific discipline.
• 8+ years of pharmaceutical industry experience in quality, production, engineering, or a laboratory setting.
• 3+ years of specific validation experience (equipment, process, computer, analytical, or cleaning validation).
• Proven experience authoring and executing quality and validation documentation such as protocols and reports.
• Solid knowledge of FDA cGMP requirements.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Strong technical writing, analytical, and organizational skills.

Preferred Qualifications

• Advanced degree in engineering or a related scientific discipline.
• Direct QA pharmaceutical experience.
• Experience with application software such as Trackwise, SAP, IDEA, or RECORD.

Benefits

• Annual performance bonus and share potential.
• 401(k) program with company match.
• Generous paid time off (PTO) and 11 company-paid holidays.
• Comprehensive health, dental, vision, and mental health benefits.
• Tuition reimbursement and career advancement opportunities.
• Paid maternity and parental leave.

About the Company

Hikma Pharmaceuticals is a developer, manufacturer, and supplier of essential medicines. With a mission to bring Better Health Within Reach Every Day, Hikma provides high-quality generic, specialty, and branded pharmaceutical products to hospitals, physicians, and pharmacists worldwide.