One of our client in PharmaEng domain is currently seeking Computer Systems Validation consultants to join our team for projects in the Toronto, ON area. The ideal candidates will have expertise in at least one of the following areas: 1) I.T/Network systems 2) Laboratory Instrumentation
Develop and execute documentation for validation and qualification activities to support various computer system validation projects.
Documents to be authored may include: Project Validation Plan, Requirements Trace Matrix, Risk Assessment, IQ/OQ/PQ, Validation Summary Report, Data Transfer and Integrity Testing Protocol, Change control, SOPs, etc.
Support development of validation deliverables, such as Functional Requirements Specification (FRS), Detailed Design Specification, etc
Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control, etc.
Ensure compliance of computerized systems to relevant regulatory requirements (e.g. cGMP/GLP/GAMP/GALP).
Complete assigned projects and tasks within agreed deadlines.
Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects
Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports
Prepare validation documentation packages and complete validation of Computerized Laboratory Systems
Acts as liaison between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guidelines.
Assist in the development of a validation remediation strategy, as required
Improve data quality of the system, harmonizing when necessary through the development and implementation of change controls (patches), or implementing a process to improve the quality of the information.
Ensure accuracy and timeliness of manual migration data updates
Network / IT Systems
(CS degree, Programming, network architecture, Database Management or a scientific background with extensive IT experience
Business Analyst role in IT department
Client server systems (Empower, Open Lab, Oracle, My SQL)
SAP or similar ERP (Enterprise Resource Planning system)
LIMS (Laboratory Information Management System) or equivalent
Web Based Applications
Hands-on experience in GMP Lab environment and execution of CSV for lab instruments.
Scientific background (Chemistry, Biology), or IT background (with specialty / experience in Lab systems)
Agilent systems (HPLCs, LCMS, GCs)
Waters systems (HPLC, LCMS)
Plate Readers (Softmax Pro), Plate washers,
Spectrophotometers (Beckman, Agilent)
DNA Sequencers (Sciex, Roche)
Bachelor’s degree in business/technical area or comparable education/experience
A minimum of 7 years’ experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment including authoring and execution of IOQ/PQ’s, experience in performing traceability matrices, risk assessments
Solid understanding of Computer Systems Validation of Manufacturing and Packaging systems
Working knowledge of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GLP and Good Automated Laboratory Practice (GALP)
Must have strong hands-on, end-to-end CSV project experience and application of project controls - including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management.
Solid understanding of data integrity risks
Ability to manage complex projects and timelines in a matrix team environment
Ability to independently identify compliance risks and escalate when necessary
Please send your resumes at email@example.com