What are the responsibilities and job description for the CQV Specialist position at Katalyst CRO?
Responsibilities
- Perform commissioning, qualification, validation, and maintenance activities within the facility.
- Oversee multiple CQV projects, providing updates and coordinating with internal teams and external vendors.
- Lead and support quality investigations, CAPAs, and process improvements to enhance compliance and efficiency.
- Develop and implement remediation efforts and CAPA plans to resolve issues.
- Author and manage CQV protocols, summary reports, change controls, SOPs, and technical documentation.
- Contribute to risk assessments, FMEAs, project planning, master plans, and annual product reviews.
- Collaborate closely with Quality, Manufacturing Operations, Facilities & Engineering, Supply Chain, and other teams to drive success.
- Bachelor's degree in science, Engineering, or a related technical field.
- At least 2 years of relevant experience, preferably in an aseptic manufacturing or cell therapy environment.
- Strong knowledge of cGMP regulations, FDA/EU guidelines, and Good Tissue Practices (cGTP).
- Expertise in CQV processes, process optimization, and regulatory compliance.
- Experience working with batch records, SOPs, CQV protocols, and technical documentation.
- Excellent analytical, organizational, and communication skills.
- Familiarity with TrackWise, Comet, CMMS, Veeva, Maximo, Kneat, Kay, and AVS/Validator is a plus.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
