Katalyst Healthcares and Life Sciences
Responsibilities:
- Resolution of fundamental Computer System Validation compliance issues on assigned projects.
- Writing, reviewing, and executing computer validation documentation.
- Perform computer system validation activities related to process control systems of pharmaceutical water for injection system, water pretreatment system, water stills and high-quality steam generation systems.
- Validation of computerized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report).
- ssessing electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach to suggest the most appropriate mitigation/remediation actions.
- Ensuring that all project-related issues and deviations are recorded, approved and dispensed accordingly.
- Preparation of project and life-cycle reports and review/approve all other documents to ensure compliance with SOP.
- Ensuring that all project and lifecycle documents achieve the goal of traceability, and are all retained in the document repository (Document Navigator) and approved following the prescribed SOP.
- t least 8 years s of experience in the pharmaceuticals field, with focus on Computer System Validation.
- Previous work experience in computer system validation of PLC's, HMI's, SCADA and historian.
- Experienced in computer system validation of Rockwell Factory Talk, Microsoft SQL Server, Microsoft NET Framework and Allen Bradley PLC systems preferably related to process control systems.
- bility to perform input and output testing.
- Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and process control systems.
- Strong knowledge in good documentation practices.
- Knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11.
- Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11).