Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Provide application/system validation expertise for standalone, enterprise, and integrated systems in a regulated (GxP) environment.
- Lead OT system qualification and validation, including Client/DCS integrated with manufacturing equipment.
- Support qualification activities in Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
- Author and review Validation Plans, Test Scripts/Protocols, and Validation Summary Reports.
- Ensure alignment with SDLC deliverables and IT Quality Management Systems (IT QMS).
- Conduct and manage risk assessments, deviations, investigations, CAPA handling, test management, and compliance activities.
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP5 guidelines and other regulatory requirements.
- Validate Standalone Systems and support ISA95-based manufacturing integration.
- Collaborate with Manufacturing, Quality, and Engineering teams to ensure successful validation and compliance.
- Consider OT Security requirements during qualification and validation projects.
- Contribute to Agile/DevOps-based validation approaches.
Requirements:
- 8–9 years of relevant experience in CSV/IT Quality & Compliance within the Life Sciences industry.
- Expertise in OT system qualification/validation, especially:
- Client/DCS systems integrated with manufacturing equipment.
- Radio Ligand Therapy (RLT) or critical dosage forms (preferred).
- Strong knowledge of Manufacturing, Quality, and Engineering system validations.
- Experience with risk management, deviation/defect handling, investigations, CAPA handling, test management & compliance.
- Hands-on experience authoring validation documentation (VP, IQ, OQ, PQ, VSR).
- Deep understanding of 21 CFR Part 11, EU Annex 11, GAMP5 guidelines.
- Familiarity with Standalone and Enterprise system qualifications.
- Knowledge of ISA95 architecture for manufacturing operations.
- OT system qualification in Radio Ligand Therapy or critical dosage forms.
- Client/DCS qualification with integration experience.
- Knowledge of MES, QMS (Track Wise), LIMS, Empower CDS, Chrome Leon, Business Analytics, Middleware systems.
- Experience with OT Security requirements in regulated environments.
Nice to Have Skills:
- Hands-on experience with testing/validation tools such as:
- Client ALM.
- Kneat.
- ServiceNow (SNOW).