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Consultant /
Provide regulatory compliance and computer validation guidance and support
to KPMG clients
• Participate is fast paced engagements, managing a team of 3-5 resources
AM, •
•
Assist in developing Software Development Life Cycle (SDLC) CSV strategy,
templates and standard operating procedures
Create system validation deliverables (validation plan, user requirements, risk
Managemen •
analysis, test protocols, validation reports)
Perform a risk analysis; Plan and coordinate the validation testing and
t Consulting
perform system audits for compliance with best practices and regulatory
requirements
– Life
Sciences – Required
Education / professional Prior Experience:
CSV
qualifications The candidate must have 4-8 years of relevant
MBA from a reputed college experience in a similar role, working with life sciences
companies.
Manager,
Assist in developing Software Development Life Cycle (SDLC) CSV strategy,
templates and standard operating procedures
• Support Regulatory Affairs transformation projects for Life Sciences clients
Managemen •
•
Perform analysis on regulatory-related data, processes, business
requirements, operating models, etc.
Support delivery of advisory services to Life Sciences clients, primarily with
t Consulting services related to product serialization, supply chain process and solution
design
– Life
• Lead gap assessments to determine the client's current state, and develop to-
be processes, including options and recommendations for critical issues
• Document serialization requirements, data architecture models, and
Sciences •
pharmaceutical supply chain processes
Provide input into engagement decisions, including work plan and timeline,
project management, resource allocation, and career development of staff
members
• Execute process transformation, measurable improved operational
performance, and organizational restructuring
About us
• Identify and communicate performance improvement opportunities for clients
Consultant /
project deliverables, review the work product of associates, and provide
direction and training as necessary
• Provide input into engagement decisions, including work plan and timeline,
AM,
project management, resource allocation, and career development of staff
members
• Perform analysis on regulatory-related data, processes, business
Managemen •
requirements, operating models, etc.
Execute process transformation, measurable improved operational
t Consulting
performance, and organizational restructuring
• Identify and communicate performance improvement opportunities for clients
– Life
Sciences – Required
Education / professional Prior Experience:
Regulatory
qualifications The candidate must have 4-8 years of relevant
MBA from a reputed college experience in a similar role, working with life sciences
Operations
companies.
Consultant / • Lead gap assessments to determine the client's current state, and develop to-
be processes, including options and recommendations for critical issues
AM,
• Document serialization requirements, data architecture models, and
pharmaceutical supply chain processes
• Create dashboards and trackers to measure the progress and performance of
Managemen •
supply chain and regulatory operations processes
Support the creation of KPMG service offerings in the form of marketing
t Consulting
collaterals and proposal presentations
• Support engagements according to KPMG's financial/cost management
policies
– Life
Sciences – Required
Technical
Education / professional Prior Experience:
qualifications The candidate must have 4-8 years of relevant
MBA from a reputed college
Operations
experience in a similar role, working with life sciences
companies.