Maintain the highest standards of product quality in a pharmaceutical or similar GMP environment
Requirements
- Proficiency in validation tools and methodologies
- Experience with automated testing frameworks
- Strong understanding of software development life cycle (SDLC)
- Familiarity with relevant industry standards and regulations (e.g., ISO, FDA, GMP)
- Relevant certifications (e.g., ISTQB, ASQ) are a plus
Responsibilities
- Govern validation activities for equipment, processes, computer software, and cleaning validation
- Approve comprehensive test plans, test cases, and test scripts based on product requirements and specifications
- Ensure oversight for execution of validation protocols and test cases, and provide approval
- Continuously review and improve validation processes and procedures to enhance efficiency and effectiveness
- Ensure all validation activities align with company policies, industry standards, and regulatory requirements
- Work closely with multi-functional teams, including development, validation, engineering, product management, and regulatory affairs, to ensure quality objectives are met
Other
- An Associate's degree is minimally required; A Bachelor’s degree in Computer Science, Engineering, or a related field, or an advanced degree is highly preferred
- Minimum of 5-7 years of experience in quality assurance in a pharmaceutical or similar GMP environment, with at least 3 years in a quality validation role
- Strong verbal and written communication skills, with the ability to effectively convey complex information to diverse collaborators
- Excellent problem-solving skills and attention to detail
- Available for urgent off-hours questions
