Validation QA Specialist

QA (Senior) Specialist - Validation

Job Summary

To clearly define the job description and qualifications of Validation QA.

Responsibilities

• Be responsible for establishing and maintaining effective qualification and validation systems, ensuring compliance with the latest regulatory expectations.
• Review and approve qualification and validation-related procedures.
• Act as the QA point of contact, participating in all commissioning and qualification activities at the WuXi XDC Singapore site, overseeing the execution of facility, equipment, instrument qualifications, computerized system validation, cleaning validation, etc., to ensure compliance with relevant regulatory requirements.
• Review and approve validation-related documents, including but not limited to URS, SIA, DQ, IO/PQ protocols, reports, etc.
• Ensure that the company’s CQV policies and procedures are strictly followed during initial qualification and requalification processes.
• Participate in the investigation of issues arising during qualification and validation activities, assess their potential impact on validation status, and review and approve the investigation reports.
• Review and approve changes during qualification and validation activities, ensuring impacts are thoroughly assessed and do not adversely affect the facility, equipment, or validated systems.
• Deliver qualification and validation-related training in line with the latest regulatory requirements and industry guidelines.
• Participate in internal and external audits as an SME, collaborating with the validation team to address observations and develop CAPA plans.
• Perform other tasks as assigned by leadership.

Qualifications

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in validation.
• Familiar with the lifecycle of facility and equipment qualification, process validation, cleaning validation, and computerized system validation (e.g., LIMS, TrackWise, Empower, etc.).
• Knowledgeable about FDA, EMEA, and PIC/S GMP requirements, as well as relevant guidelines issued by PDA, ISPE, etc.
• Extensive experience in aseptic process validation and cleaning validation in the biopharma industry is preferred.
• Experience with new site construction and startups is preferred.
• Proficient in English listening, speaking, reading, and writing.
• Skilled in Microsoft Word, Excel, PowerPoint, etc.
• Strong problem-solving skills.
• Logical thinker.
• Strong learning ability.
• Skilled in cross-functional communication and collaboration.