What are the responsibilities and job description for the Quality Assurance Validation position at Katalyst CRO?
Roles & Responsibilities
- Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.
- Provide QA oversight for periodic review and requalification program.
- Perform review of CMMS records related to asset management including asset release, database requests, and work orders.
- Author and perform review of SOPs in Veeva.
- Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation).
- Ensure compliance of validation activities with applicable GMP regulations, industry guidance, and internal SOPs.
- Collaborate with cross-functional teams (Validation, QA, Engineering, Manufacturing, QC) to support timely execution of validation projects.
- Participate in change control assessments, risk assessments, and deviation investigations related to validation.
- Provide QA input during validation planning and execution phases.
- Support audits and regulatory inspections by providing validation documentation and addressing QA-related inquiries.
- Ensure data integrity and documentation accuracy in all validation records.
- Requirements :
- Bachelor's degree in a technical discipline with 5 years validation and/or quality assurance experience. In lieu of degree, 7 years of equivalent work experience is required.
- Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.
- Prior experience working in cell and gene therapy manufacturing preferred.
- Prior experience working with contract manufacturing preferred.
- Experience with Kneat strongly preferred.
- Applies collaborative approach to problem solving and is experienced with risk-based decision making.
- Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.
