Computer Systems Validation

at  Pharmeng Technology Inc

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.
We are seeking an experienced Computer System Validation Consultant for a project in based Toron, Ontario, to help drive our solution-based business model and take our designs to the next level. Our consultants have the chance to work hands-on with several business divisions to design, develop, test industry-leading solutions for our clients—both nationally and internationally. Our ideal candidate is a creative thinker who shares our passion for making people’s lives easier.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in business/technical area or comparable education/experience.
• A minimum of three (3) to five (5) 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.
• Strong technical skills in hands-on configuration of a variety of Laboratory systems including Standalone instruments such as Mass Spec, IC, Matersizer, UV, FTIR, DSC etc.
• An understanding and ability to configure TCP/IP network connectivity between systems.
• Excellent Desktop Operating system knowledge with respect to Permissions, configuring users and connecting to peripheral devices. Including Windows 2000, Windows 7 and Window 7
• Drive mapping, logon scripts, Analyzing System logs.
• Good understanding of Active Directory and Domain permissions. LDAP understanding.
• An advanced understanding of security of data systems for the protection of electronic assets, intellectual property, and privacy.
• Experience in developing and implementing complex data exchange technology processes between information systems.
• Experience in creating/developing a moderate to complex functional requirement mapping to an Information System based on user requirements.
• Ability to independently identify compliance risks and escalate when necessary.
• Must be a self-starter with great team communication skills; and
• Must have proven ability to lead a team.

• Preparation of Validation protocols for GxP critical reports;
• Configuration of static Master Data objects in a validated/GMP compliant LabWare LIMS (version 6) environment;
• Assist in protocol execution, review, and approval;
• Generation of Change requests and IT tickets for the validation of reports;
• Validation of business intelligence reports and skilled with all the tests required to properly qualify the reports;
• Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects;
• Develop and execute documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include URS, FRS, FRA, HLCCD, 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);
• Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports. Prepare Validation Plans, IQ, OQ, Validation Summary Reports;
• Acts as liaison between Quality Assurance and project team to assure that GxP software is implemented in compliance with applicable regulations and guidelines;
• Responsible for planning and managing a project to successful completion, within the established deadline and within the budget;
• Possess excellent management skills to coordinate with the team, the clients, and stakeholders;
• Manage day-to-day operational aspects of the project and scope;
• Ensure project documents are complete, reviewed, approved, and stored appropriately; and
• Keep project team well informed of changes within the project.