Our Life Sciences Division has played a critical role in delivering consulting services around Regulatory Compliance and Computer Systems Validation to various pharmaceutical, biotechnology, and medical device organizations clients across the US and throughout the world to help our clients deliver compliant solutions.
Opportunity: We are seeking a quality experienced ERP Implementation Specialist to join our Life Sciences division.
Location: Anywhere in the US
Responsibilities: Qualified individuals will provide the following consulting services to our clients:
Validating “ERP” systems using established Computer System Validation (CSV) methodology such as GAMP®5 and GAMP Good Practice Guides
Execute quality assurance or authorship role on ERP SDLC processes such as: User Requirement Specifications, Functional Specifications, Business Process Mapping, Workflow Designs, Design Reviews, Design Specifications, Requirements gathering and Management, Risk Assessments, IQ/OQ/PQ Protocols, Traceability, Configuration Management, Change Control, Incident and Deviation Management, SOPs, Test Strategy/Plans/Scripts, Validation Master Plans, Validation Summary Reports
Provide guidance and facilitate regulatory Risk Assessments of Gap systems to established standards
Maintain expertise in current and emerging camp requirements and quality trends
Recommend and execute changes to quality standards to ensure conformance to regulatory requirements and industry current "best practice"
This position will entail travel a minimum of 75% travel
Experience with pharmaceutical, medical device, and biologic manufacturing
Experience in working with SDLC industry principles (e.g., GAMP, IEEE, etc.)
Knowledge of FDA validation requirements as they relate to the pharmaceutical, medical device and biologics industries
The ability to manage projects of a diversified scope and be able to influence cross-functional teams to achieve internal and external compliance requirements.
Expertise in current and emerging gap requirements and quality trends
Some knowledge of implementation tools used in the industry a plus; Mercury Interactive Test Director, Rational Requisite Pro
7+ years of experience with compliance and validation
3+ years of experience with ERP
5+ years of experience in IT/IS
Proven analytical and communication skills, both written and oral
The ability to work independently or as part of a team
Proven organizational skills and project management skills
Business & Decision, North America is proud to be an equal opportunity employer M/F/D/V
+1 646 507 5240