Quality Assurance Engineer - Validation

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

• Experience in pharmaceutical manufacturing, including solid oral dosage, sterile injectables, or biologics preferred.
• Strong understanding of cGMP, FDA 21 CFR Part 210/211, EU GMP, and ICH guidelines.
• Proficient in process validation lifecycle (IQ/OQ/PQ), risk management (FMEA), and quality risk assessments.
• Familiarity with statistical tools and software (e.g., Minitab) for data analysis and process capability studies.
• Knowledge of Measurement System Analysis (MSA) and equipment qualification is desirable.
• Proficient in reading and interpreting technical specifications, batch records, and validation documentation.
• Strong project management and time management skills.
• Excellent written and verbal communication skills, including experience with regulatory audits and customer interactions.
• Commitment to quality, compliance, and continuous improvement.

Education and Job Experience Requirements

• Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field (or equivalent experience).
• Minimum of 3-5 years of experience in a pharmaceutical quality engineering or validation role.