Quality Assurance Validation Specialist - GMP & CSV

Takeda Pharmaceutical Co.; Thousand Oaks (CA); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda Pharmaceutical Co. in Thousand Oaks, CA, is seeking a Quality Assurance Validation Associate to provide QA oversight of validation deliverables and change controls across facilities, utilities, equipment, and computer systems validation.

You will review Master Plans and IQ/OQ/PQ/CSV packages, assess risk, ensure traceability, and support regulatory submissions. The role requires GMP experience, data integrity focus, and collaboration with cross-functional teams.

Qualifications

• Responsible for reviewing validation documents, against Standard Operating Procedures (SOPs) for accuracy and compliance with procedures, based on regulatory requirements and internal guidelines.
• Review from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.
• Responsible for reviewing Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages in accordance with existing procedures. Reviews deliverables for compliance with existing requirements. Approves documentation related to system decommissioning.
• Provide validation expertise and support for the development (or modification phases) of manufacturing facility, utilities, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
• Participate in the risk assessment related to the project.
• Assure requirements traceability throughout the whole project life cycle.
• Provide support in all quality-related issues, including GMP regulations
• Assess and approve Change controls, CAPAs and deviations to ensure conformance to regulatory agency requirements, company standards and industry best practices
• Take part in internal/external audits.
• Maintain project metrics to communicate risk trends and implementation readiness to support project timelines and commercial readiness
• May perform other duties as assigned.

Responsibilities

• Review validation Master Plans, IQ/OQ/PQ/CSV packages and related documents.
• Support regulatory submissions through QA review of validation deliverables.
• Provide guidance on validation maintenance and decommissioning.
• Ensure QA requirements across projects and systems.

Skills

Validation experience

GMP knowledge

Quality documentation

Cross-functional team

Risk assessment

Data integrity

Regulatory submissions

Education

Bachelor’s Degree in Biotechnology, Microbiology, Pharmacy or equivalent

Tools

Veeva

Kneat

ALM

Job description

Takeda Pharmaceutical Co. in Thousand Oaks, CA, is seeking a Quality Assurance Validation Associate to provide QA oversight of validation deliverables and change controls across facilities, utilities, equipment, and computer systems validation.

You will review Master Plans and IQ/OQ/PQ/CSV packages, assess risk, ensure traceability, and support regulatory submissions. The role requires GMP experience, data integrity focus, and collaboration with cross-functional teams.