Computerized / Non-Computerized Equipment, Process, Facility and Utility Validation 70%
Provide quality support to the evaluation of software applications and firmware associated with computerized systems and equipment used in laboratories, clinical manufacturing and facilities / utilities
Provide technical support to the design and system configuration including coding and macros, network interface and PID
Ensure validation is in compliance with 21 CFR part 11, where applicable
Provide final review and approval of all computer / non computer validations design and execution.
Advise on test requirements, scope, and acceptance criteria as per project deliverables.
Ensure that the methodology used in qualification testing will thoroughly test and challenge.
Review and approve development documentation for GMP compliance, business risk, and consistency.
Provide and monitor non-conformance results during the validation studies to determine acceptable remediation / corrective actions.
Perform Vendors’ and in-house audits (approximately 10 - 15 % Travelling)
Ensure all required documentation to be provided by vendor / consultant will allow Aventis Pasteur Canada to be self - reliant and compliant
Project Team representation 10%
Coordinate with user / system owner to perform validation as per the designated validation protocol.
Provide subject matter expertise during External and Internal Regulatory Inspections defending the programs and the individual validated equipment / systems and providing timely and technically completed responses to audit observations.
Represent Quality on key company projects to endure project deliverables are attained from a validation perspective.
Collaboration on Local & Global Quality Initiatives 10%
Participates in on-going global quality initiatives.
Keeps updated on new rules and industry regulations, and to define and align internal quality systems with best practices.
Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.
Participates in global R&D QA initiatives impacting quality systems to ensure harmonization of processes. Works with global R&D QA colleagues on action plans for remediation and / or implementation.
Participates in local customer service initiatives including those focusing on improving R&D QA support.
Training & Interactions 5%
Develop and maintain site policies and procedures that describe validation initiatives that are aligned to regulatory requirements and global Quality and Industry standards.
Update and / or provide training to users on validation policies and procedures.
Development documentation consists of specifications, protocols, plans, training material and SOPs for systems including stand alone and custom built systems (ie.
Automated systems, Analytical tests equipment including macros for calculations methods).
Incumbent must remain current of changing regulatory environment and new approaches to validation design / approaches.
The incumbent must provide to users, EIT and purchasing; quality and technical support related to the evaluation and purchase of equipment, business and Facility / Building Monitoring systems
Incumbent must understand computer validation methodologies such as to define the extent of validation based in intended use and / or risk assessment
Incumbent must collaborate closely with User groups including EIT and IS who execute much of the validation and to ensure the necessary planning, training, design and approvals and the resultant data are aligned to company standards and regulatory requirements.
The incumbent must be able to defend programs and provide professional and technical support during corporate and external regulatory inspections in a competent and convincing manner.
The incumbent must be familiar with changing regulatory environments in computer validation (i.e. 21 CFR Part 11, Key Industry Standards in Automation).
DIMENSIONS / SCOPE
This is a managerial position. There are no direct reports into the position, however whenever applicable guidance will be provided to junior staff and consultants.
The accountabilities of this position are local as well as global. This position is primarily accountable to local Research and Development, however decisions made and actions taken may have an impact on all departments at the Canadian and French R&D sites with respect to Computer Systems and equipment.
All operating areas in R&D and Clinical Manufacturing / Testing as well as some business support areas including Information Systems.
Incumbent will also work in global environment in development test practices and supporting the development of global Quality documents and standards supporting validation.
Minimum, B.Sc. or Equivalent in Computer and / or Engineering Sciences. Formal training in computerized system validation, GAMP, and CFR 21 part 11 is an asset
Degree in MBA and certifications in Project Management and / or Six Sigma also an asset
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