Katalyst CRO
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Quality Assurance Validation
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Katalyst CRO . 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 review 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 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 with validation documentation and QA inquiries. Ensure data integrity and documentation accuracy in validation records. Requirements: Bachelor's degree in a technical discipline with 5+ years validation and/or quality assurance experience, or 7+ years of equivalent work experience. Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation. Prior experience in cell and gene therapy manufacturing preferred. Experience with contract manufacturing preferred. Experience with Kneat strongly preferred. Collaborative problem-solving and risk-based decision-making skills. Team player capable of working in multidisciplinary groups. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
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Quality Assurance Validation
role at
Katalyst CRO . 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 review 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 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 with validation documentation and QA inquiries. Ensure data integrity and documentation accuracy in validation records. Requirements: Bachelor's degree in a technical discipline with 5+ years validation and/or quality assurance experience, or 7+ years of equivalent work experience. Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation. Prior experience in cell and gene therapy manufacturing preferred. Experience with contract manufacturing preferred. Experience with Kneat strongly preferred. Collaborative problem-solving and risk-based decision-making skills. Team player capable of working in multidisciplinary groups. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr