Senior QA Specialist
Company:
Our client is a global biotechnology company specializing in innovative therapies. Renowned for groundbreaking research in life-changing treatments. Committed to improving patients’ lives through cutting-edge science. A leading force in the healthcare industry, driving advancements worldwide.

Role Description:
You’ll Conduct QA oversight for equipment, automation, and information systems validation, as well as Quality Risk Management. Review and approve validation documentation for equipment and automation, ensuring compliance with Corporate, Site, and Regulatory requirements. Offer guidance and direction to operations staff on adhering to quality policies, standards, and procedures and provide quality engineering support for testing strategies and investigations.

Responsibilities:

• Handling process, equipment, and IS validation.
• Guiding design, characterization, and validation in collaboration with Product Development (PD) Or Monitoring and Evaluation (M&E) Or Information System (IS).
• Approving validation documentation.
• Reviewing and endorsing equipment and Monitoring and Evaluation (M&E) procedure changes.
• Managing device and combination product matters, ensuring alignment with corporate policies. Additionally, recognizing, and escalating issues or risks affecting project quality delivery and timelines.

Requirements:

• A minimum of 2+ years of relevant experience within the pharmaceutical or medical device sector, including expertise in Equipment and Automation Validation.
• Proficient in Good Manufacturing Practice (GMP), equipment and automation/ Information System (IS) validation, and computer compliance. Able to interpret and apply these principles in routine scenarios.
• Familiar with manufacturing and quality analytical processes and operations.
• Skilled in handling Non-conformances, CAPAs, and Change Control.
• Possesses a strong grasp of quality engineering tools.