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CGI Life Science is seeking career driven management quality management validation resources with strong testing and analysis skills to join CGI Life Sciences Industry Practice Team. We are experiencing rapid growth and are looking to expand our capabilities based out of our Philly Metro, supporting clients throughout North America
This role must be located at one of the following locations: Lava, Canada; Seattle, WA; Indianapolis, IN.
Your future duties and responsibilities:
Quality Validation Resources possess strong analytical skills and detailed understanding of the solution validation processes across regulated and non-regulated systems. They objectively evaluate information gathered from multiple sources, reconcile conflicts, breakdown high level information into details, and abstract up low-level information to a general understanding distinguishing user requests from the underlying needs of the business.
Strong understanding of any of the following : 21 CFR Part 11, 210, 211, 820(Quality System Regulations) , FDA, Risk Assessment, GAMP 5, Gap Analysis, Remediation, Retrospective Validation, Change Control, CAPA.
Required is LIMS Validation Experience. Preferably with LabVantage / LIMS
Successful individuals will have significant experience within the Bio-Pharmaceutical Manufacturing Quality domain. Knowledge of Quality & Manufacturing (good manufacturing practices (GMP)) business process for biotech or pharmaceutical industry. Specific expertise with Document and Change control process is required Analyze and validate quality management business processes (e.g., developing quality manuals, interpretations of regulations, policies, and related quality management SOPs). Assess and work with clients on quality management gaps, provide recommendations on remediation \
What you’ll be doing:
• Collaborates with clients, subject matter experts, and technical teams to execute the solutions validation deliverables for planning, development, and implementation and testing
• Contribute to the execution and documentation for deliverables such as Validation Master Plan, CSV Regulatory Risk Assessment, Validation Protocols (IQ, OQ, PQ), URS, FRS, Requirement Traceability Matrix (RTM), and Validation Summary Report.
• Demonstrates strong analytical skills and detailed understanding of solution validation processes including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.
• Serves as the conduit between the customer community (internal and external customers) and the services teams in which the validation deliverables flow.
• Exhibits knowledge of emerging industry practices when solving business problems.
• Documents complex business processes using a combination of diagrams and explanation.
• Identifies critical issues with ease
Required qualifications to be successful in this role:
Skill Set/Years of Experience
SDLC, QMS System, LIMS
Regulated and Non Reg Systems GXP GMP
Minimum Education Required: Bachelors Degree
Est. Salary Range (Colorado Only): $84,000-$115,000*
*Disclaimer: In accordance with Colorado’s Equal Pay for Equal Work Act, effective January 1, 2021, a good faith hourly or base salary range must be posted for all positions where the work may be performed in the state of Colorado. Therefore, this good faith salary range will only apply where this described position will be performed in the state, and should not be considered the compensation range in other locations or for other positions.
At CGI we call our professionals “members” to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI’s benefits include:
• Competitive base salaries
• Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category
• 401(k) Plan and Profit Participation for eligible members
• Generous holidays, vacation, and sick leave plans
• Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment;
• Back-up child care, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more
What you can expect from us:
Build your career with us.
It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
Be part of building one of the largest independent technology and business services firms in the world.
Learn more about CGI at www.cgi.com.
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CGI is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
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