Quality Assurance Engineer - Validation

Quality Engineer – Pharmaceutical Manufacturing

Seeking a Quality Engineer to lead quality assurance activities across the pharmaceutical product lifecycle, from development through validation and commercial production. This role involves applying cGMP principles, managing validation protocols (IQ / OQ / PQ), analyzing process data, and supporting cross-functional teams to ensure compliance, efficiency, and product quality. Ideal candidates will have experience in pharmaceutical manufacturing, strong statistical and project management skills, and a solid understanding of regulatory requirements.

Essential Duties and Responsibilities

• Develop, implement, and maintain the company's pharmaceutical quality assurance strategy across all stages of product development and manufacturing, in alignment with cGMP and ICH Q8 / Q9 / Q10 guidelines.
• Lead the planning and execution of quality assurance deliverables and product testing activities, ensuring compliance with regulatory requirements and internal standards for new drug product launches.
• Perform statistical analysis of process and product performance data to assess capability and ensure conformance to internal and regulatory specifications.
• Author and review validation protocols and reports (IQ / OQ / PQ) in accordance with FDA, EMA, and other global regulatory expectations.
• Provide guidance to quality personnel on procedures for sampling, testing, and data documentation in compliance with Good Laboratory Practices (GLP).
• Collaborate cross-functionally with R&D, Regulatory Affairs, Manufacturing, and Supply Chain teams to support daily operations and continuous improvement initiatives.
• Support new product introductions by ensuring robust and compliant manufacturing processes that are efficient and cost-effective.
• Manage multiple projects and timelines across various pharmaceutical programs and clients.

Required Competencies, Skills, and Experience

Education and Job Experience Requirements