Job Description

Job Description

Job Description

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).
• Assessing 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.

• At 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.
• Ability 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).

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