Overview
On Site
Full Time
Skills
Writing
Pharmaceutics
V-Model
IQ
OQ
Traceability Matrix
Reporting
Regulatory Compliance
SOP
Pharmaceuticals
FOCUS
HMI
SCADA
Computerized System Validation
Microsoft SQL Server
.NET
Allen-Bradley
Programmable Logic Controller
Testing
Lifecycle Management
Process Control
Documentation
Data Integrity
GMP
GAMP
Job Details
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).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.