Senior Business System Analyst/Expert -Quality Computer Systems

カナダ, オンタリオ州, Mississauga

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Sr. Business Systems Analyst

Function: Global GMP Computer Systems

Department: QSQM

Location: Mississauga

Job Family: Quality Systems

Reports to: Head of QA Computer System Ownership          


As a Computer Systems Subject Matter Expert in Global Quality Systems and Management, you are responsible for understanding the strategic drivers and needs of the PT and PTQ organization. You will provide global subject matter expertise and support the implementation of the fit for purpose innovative solutions, including the information framework supporting the E2E process through the software development lifecycle (SDLC).   A successful candidate will have an agile and design thinking mindset and may perform as the Product or Process Owner.

Key Responsibilities/Tasks:

●     Provide Subject Matter Expertise for Quality Computer Systems (e.g., QMS, EDMS, ECM)

●     Ensure GMP Computer Systems and their operation are in compliance and fit for intended use according to applicable   procedures

●     Approve major upgrades and the replacement and/or retirement of computerized systems through change management processes

●     Oversee system access process / procedures including periodic review of user access lists

●     Determine how to verify data integrity and propose strategies to achieve better data accuracy

●     Manage the escalation of issues to Business or IT and communicate/document status of issues where appropriate

●     Give input into and help define validation test strategy

●     Works with management to align projects to strategy and business objectives

●     Serves as ambassador for measurement, accountability and a disciplined approach to process improvement within the department and across functional area

●     Lead or participate in interdepartmental teams, process improvements, or new system design

●     Leads meetings and or represents organization on projects, support and/or significant issues

●     Make informed decisions on software issues in collaboration with key stakeholders and abiding by system requirements

●     Ensure the smooth introduction of new functionality of the software as they are added

●     Regularly evaluate business use of the software and training materials to ensure alignment according to intended use

●     Initiate, investigate and close complex investigations and discrepancies

●     Lead or participate User Group Forums both locally and across sites

●     Attend or present at Vendor User Group Conferences

●     Possess analytical and/or computer skills sufficient to:

●     Understand data requirements and inter-dependencies

●     Solve problems through effective troubleshooting and suggest viable solutions

●     Continuously improve systems achieving increased compliance and efficiency

●     Use influence rather than authority when necessary to achieve results

Job Qualifications: Education, Experience, Knowledge and Skills:

●     Bachelor’s Degree in an applicable field or equivalent, MBA a plus

●     Minimum 7-10 years of work experience in biopharmaceutical production and an understanding of quality processes and procedures  

●     Experience with validated or controlled environments preferred

●     Demonstrated proficiency in Software Development Lifecycle (SDLC) 

●     Working knowledge of one or more information packages (e.g., QMS, EDMS, ECM)

●     Experience using Lean Production System (LPS) for continuous improvement opportunity evaluation

● Knowledge of software systems (QMS, EDMS - Veeva product is a plus) and the ability to navigate relational databases

● Capability to use data analysis to understand correlations, trends, and provide recommendations for optimization of systems and data workflows based on these insights.
● Proficiency in use of data analytics tools to drive business decisions

●     Leadership and project management, including understanding of life cycle planning

●     Demonstrated ability to influence and lead both with and without authority

●     Strong interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner

●     Flexibility in problem solving, providing direction and work hours to meet business objectives

This position is not eligible for relocation support.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks. 

AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Roche is an equal opportunity employer.

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