The Quality and Manufacturing Senior Consultant should have 5-10 years of experience in Pharmaceutical, Biotech, and/or Medical Device Commercial Manufacturing and Quality. He/she must have experience leading projects and/or implementations in GxP environments. He or she must be comfortable and proficient in interacting directly with clients on an ongoing basis and managing their expectations. In addition, the candidate should be adept at managing the people, process and technology for eliciting business requirements, translating business requirements into system requirements, and managing clarifications between business and technical teams. Experience with Computer Systems Validation (CSV) and the Solution Delivery Lifecycle (SDLC) are also key qualifications.
• Provides subject-matter expertise and support to Quality & Manufacturing Project and Business Development teams as needed in the following areas:
* Laboratory Information Management Systems
* Sample Receipt / Management
* Standards & Reagents
* Chemical Inventory Management
* Electronic Lab Notebooks
* Laboratory Equipment Management Systems (Empower, Blue Mountain, etc)
* Quality Management Systems
* Deviations, Lab Investigations, Change Controls, CAPAs, Complaints, Audits, Supplier Qualification
* Document Management Systems
* GMP Documents (SOPs, Work Instructions, Protocols, Master Batch Records, Forms, etc)
* GCP Documents
* GLP Documents
* Enterprise Resource Planning (ERP) / Manufacturing Execution (MES) Systems
Quality Transactions (Hold / Quarantine, Material / Batch Status)
* Integrations ERP/MES and other Quality systems
• Demonstrates facility in client-facing activities including:
* Eliciting and documents business requirements.
* Analyzing and validating business requirements.
* Translating business requirements into system and non-functional requirements.
* Facilitating requirements review sessions with business and IT.
* Assists business clients with developing new business processes or modifying existing business processes (during implementation, may help develop communication material; define supporting procedures and standards; document training materials; assist in the immediate training effort; etc.).
* Assists in the creation of business cases and other related financial planning, impact identification, or value justification.
• Consistently delivers on the following internal activities while fostering a collaborative environment:
* Maintains and manages requirements within requirements management tool and related SDLC artifacts.
* Performs or assists with defect or incident root cause analysis in support of incident and problem management processes.
* Performs or assists with other functions including vendor coordination, planning, project management, release management and change management as assigned and actively participates in special projects as assigned.
* Adheres to Solution Delivery Lifecycle (SDLC) and IT Service Management (ITSM) processes.
* Develops the right skills to meet the future needs of the organization.
* Performs or assists with production support as needed.
• Bachelor’s degree (preferred in Biology, Chemistry, Engineering, Computer Science, or Communications) OR equivalent work experience
• GxP Manufacturing Experience and/or GxP Quality Control / Quality Assurance Experience
• Excellent oral and written communication and interpersonal skills
• Highly organized
• Ability to analyze, articulate and solve problems
• Ability to learn quickly, move with agility between assignments, multi-task, and to work effectively in a team environment, both face-to-face and remotely
• Experience with LabWare LIMS applications
• Experience executing any role within the SDLC (including author, tester, coordinator, or project manager)
• Requirements development, engineering or management knowledge
• Experience with enterprise requirements management / application lifecycle management tools
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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, 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.
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