Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Perform validation activities to ensure compliance with government and customer requirements.
Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches.
Maintain existing validated processes, coordinating internal and customer approvals as needed.
Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals.
Assist in the change control process and prepare change control and validation history reports for audits.
Participate in conference calls and meetings to communicate project goals and progress.
Investigate validation deviations, document formal reports, and ensure corrective actions are completed.
Review and approve User Requirement Specifications (URS), Functional Specifications (FS), and Engineering Study Protocols.
Assist with Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment.
Coordinate validation efforts with mechanics, operators, and engineering teams.
Complete and pass GDP and GMP training courses as required.
Perform other duties assigned by managers or supervisors.
Manage high-risk projects, which may include complex customer needs, stringent validation requirements, and significant time commitments.
Requirements:
Bachelor’s degree in a related field or 1–3 years of related experience and/or training.
College-level proficiency.
Intermediate skills, including proficiency in various technical software programs.
Full professional proficiency in speaking, reading, and writing.
Experience with medical device sterilization processes and test method validation.
Familiarity with GAMP, 21 CFR Part 11, Annex 11 compliance for computer system validation.
Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
Experience developing, executing, and documenting validation protocols (IOQ, OQ/PQ) for equipment, processes, and computer systems.
Preference for medical device experience (Auto-Injector preferred), but candidates with pharma backgrounds will be reviewed.
Minimum of 3 years in a regulated industry (FDA, cGMP, pharmaceutical, medical device, or combination products).
Understanding of ISO, cGMP, FDA, 21 CFR Part 11, Annex 11, and other regulatory standards.
Proficiency in root cause analysis (RCA), CAPA, FMEA, control plans, and process risk management.