Quality Assurance Validation

13 hours ago

Boston, MA, United States Katalyst Healthcares and Life Sciences Full time
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.
  • uthor 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.
  • pplies 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.

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