Manager, Software Authority Validation
Canadian Nuclear Laboratories
- Chalk River, ON
- Permanent
- Full-time
- Implementing validation systems and validation strategies. Establish and maintain the validation master plan and CSV plan for each validation stream.
- Representing the validation department in regulatory inspections. Ensure all validation programs are designed to achieve right-first-time regulatory approval.
- Providing oversight and validation expertise during the development of new products and new technologies. Write and approve the process and equipment validation protocols.
- Participating in periodic reviews during product lifecycle to deepen process performance understanding and drive process improvement.
- Effectively monitoring and communicating the validation workload requirement and priorities and communicate the validation projects execution plan to other departments.
- Determining appropriate validation resource requirements around site plans. Provide clear visibility to the operation on the validated status of product/ equipment required for manufacture.
- Developing and maintaining the Quality Plan and associated Management System enabling documents for Analytical, Scientific and Design (ASD) Computer Programs to ensure that the requirements of CSA N286.7, at a minimum, are met;
- Ensuring that training on the ASD Software Program is available.
- Ensuring uniform and consistent grading of ASD software across CNL
- Ensuring that a list of ASD software is maintained (e.g., via the Library of Codes databases accessible from CNL intranet)
- Ensuring adherence to the ASD Computer Programs for all ASD software developed in-house or acquired from a third-party and used at CNL
- Ensuring that experience gained within CNL and other businesses on the use of ASD
- Software codes is collected, reviewed for relevance and significance, addressed through appropriate actions, and shared within the business based on its sensitivity.
- Bachelor’s degree in software, science or engineering
- 8-10 years of experience in a GMP or other regulated industry, preferably in an engineering, validation, or operations role.
- Experience managing a validation department within a GMP or other regulated environment, strategic leadership, and team development.
- A minimum of 8-10 years of relevant experience, in particular related to software engineering, software development and validation, and must have a thorough knowledge of the software quality processes by which ASD computer programs are developed.
- Experience in QA self-assessments, effectiveness reviews, surveillance, and auditing activities.
- Experience in a nuclear environment.
- Good project management skills with the ability to handle multiple activities simultaneously and deliver against deadlines.
- Comfortable presenting to customers or regulators.
- Completed project management courses recognized by PMI institutions or PMP certification are an asset.
- Demonstrated experience in communication with Health Canada (HC) and the United States Food & Drug Administration USFDA
- Knowledge of CSA N286.7 and it’s implementation in the nuclear environment.
- Strong knowledge of current industry validation guidance and best practices.
- Knowledge of EQMS (Electronic Quality Management Systems) and enterprise and data management systems, e.g. SAP, LIMS, Qualio.
- Knowledge of electronic company quality systems.
- Strong knowledge and understanding of Health Canada, FDA, ISPE process validation guidance’s and QbD (Quality by Design) approach. Knowledge of FDA, Health Canada, European Union (EU) guidance, ICH guidelines.
- Demonstrate knowledge of CSV, Electronic Records/Electronic Signatures, 21 CFR Part 11, 210, 211, and 820 principles in the pharmaceutical industry.
- Strong knowledge and demonstrated previous experience in Computer System Validation, ISPE GAMP 5 Risk Base Approach to Compliant GMP computerized systems, Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guidance on Good Practices for Computerized Systems in regulated GxP environments
- Work-life balance is an integral part of our overall health and well-being; at CNL, we value this.
- paid time off (vacation, sick, floater & personal);
- benefits effective day one, that’s right, no waiting period;
- tuition support
- and a pension!
- Clean energy for today and tomorrow.
- Restore and protect the Environment.
- Contribute to the health of Canadians.
- This role is based out of CNL’s Chalk River site, however, subject to the terms of this agreement, the primary work location will be remote. The role will require some regular and frequent attendance at the Chalk River site. The schedule and frequency will be determined by discussions with the manager as well as internal client and project needs. CNL may require travel from time to time, as necessary.