Katalyst Healthcares and Life Sciences
Responsibilities:
- Designs and drafts validation sampling and testing plan/protocols.
- Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies.
- Resolve technical issues encountered during study execution.
- Track and expedite the review and sign-off of qualification documentation.
- Support execution of validation activities.
- Interact with individuals from different departments to plan, execute, and complete qualification activities.
- Drive the completion of validation efforts according to deadlines.
- Write / guide the writing of departmental procedures required for validation.
- Assist during internal and 3rd party audits wrt validation requirements.
- Initiate CAPAs, NCRs and Change Requests where required and assist with investigations.
- Assist with identifying maintenance and calibration requirements.
- Coordinate suppliers wrt Validation activities including obtaining quotes from suppliers.
- Validation administration such as updating the validation plan, maintaining databases, standard referencing of documentation.
- Review Validation plans, protocols and SOPs written by other validation team members.
- Manage workload arising from unscheduled events.
- Other duties as assigned by management.
- Validation Protocol Development and Execution: Expertise in creating and executing validation protocols (IQ, OQ, PQ, CSV, etc.).
- Regulatory Compliance Knowledge: Strong understanding of FDA, cGMP, GAMP, and related regulatory standards.
- Technical Problem-Solving: Ability to troubleshoot and resolve technical issues during validation.
- Cross-Functional Collaboration: Effective communication and coordination with internal teams and external suppliers.
- Documentation Management: Proficiency in managing validation documents, databases, and SOPs.