Project Consultant Business Analyst
Work for a global healthcare leader. Eclaro is looking for a Project Consultant Business Analyst -PQC Simplification Project for our client in New Brunswick, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!The Project Consultant Business Analyst - PQC Simplification Project will be reporting into Quality Director, Product Complaint Management.
- Assess as-is processes, technology landscape and data to identify improvement opportunities
- Lead the business process simplification for Global Product Quality Complaints
- Drive key business process requirements gathering from Subject Matter Experts (SMEs) across Client sites and local markets
- Manage project needs and engage support from SMEs globally
- Conduct working sessions with SME for requirement definition
- Establish project milestones and work towards targeted deliverables for each work stream
- Manage the improvement activities through established project management tools
- Document detailed process flows
- Conduct functional fit-gap analysis for redesigned processes and document to-be requirements
- Develop key deliverables of User Requirement Spec (URS), Functional Spec (FRS), validation plans, risk assessment and IQ/OQ/UAT test scripts
- Prepare training material, system guides and Standard Operating Procedures (SOP) for the to-be system
- Provide project updates to project stakeholders, sponsor, and management as necessary
- Escalate issues to management in a timely manner with proposals to resolve
- Execute validation and testing activities to qualify PQC systems in GxP environments
- Partner with identified Change Champions for site readiness activities
- Perform other duties within the scope of the project as assigned.
- Requires minimum of 5-years of relevant experience.
- Experience in consulting as a business process transformation/Solutions Architect/ Validation Lead in enterprise transformation projects with focus on Quality Management Systems within a regulated health care industry.
- Have good understanding of GxP standards, 21 CFR Part 11, System Development Lifecycle (SDLC) in hybrid agile and waterfall methodologies.
- Minimum of a Bachelor’s Degree in Engineering or life sciences
- Experience in implementing quality risk management strategies within business processes
- Project Management and Six Sigma certification required.
- Strong oral and written communication skills, MS Office experience
- Project management experience
- Experience in "continuous process improvement" is required
If hired, you will enjoy the following Eclaro Benefits:
- Analyzing data and identifying issues/areas for improvement is essential.
- Ability to communicate effectively on a professional level
- This individual should have creative problem solving and critical thinking skills.
- Work with minimal supervision, engage appropriate departments, obtaining necessary information to make informed decisions and recommend solutions
- Demonstrated understanding and application of CGMPs, Quality Systems, relevant laws, guidance, and directives, and current industry practices.
- Attention to detail, ability to work and coordinate activities with multiple functional groups and with the sense of urgency
- Ability to prioritize, plan, and schedule.
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Interested in applying?
Contact Cheryl Buot at (212) 901-3840 or at www.linkedin.com/in/cheryl-buot-56ba4836 and/or send your resume to Cheryl.Buot@eclaro.com now.
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.